Gingival DiseasesPhase 3NCT00762619
Clinical Study to Examine Brushing on Dental Implants
A Phase 3 study testing Fluoride and Triclosan, fluoride in people with Gingival Diseases, run by Colgate Palmolive at 2 sites in 2 countries.
Trial summary
The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases
- What is being tested?
- Fluoride and Triclosan, fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2007to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females in good oral and general health aged 18 to 76 years.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study.
- Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
- Adequate oral hygiene and no signs of oral neglect.
- Subjects will have at least one dental implant and a contralateral natural tooth.
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- At the first visit subjects will be examined by a dentist for periodontal health.
- Selected subjects will have periodontal pockets less than 6mm.
- Subjects with gingival index equal to or greater than 1.0 and plaque index equal to or greater than or 1. 5 on the implant tooth will be enrolled. Gingival and plaque indices will be measured during the first visit for the implant. Similarly, these clinical indices (Gingival and plaque index) will be determined for the contralateral natural tooth. (The adjacent teeth will serve as a backup for the studies if control tooth is lost during study).
- Subjects who are habitual users of Colgate Total or other oral hygiene formulations with antimicrobial agents will complete a washout phase of 30 days with a commercial fluoride dentifrice prior to enrollment in the study. This washout dentifrice will be identified and obtained by the clinical investigator from an appropriate local source.
Who cannot join
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
- Regular use of mouthwash with antimicrobial agents within the past month.
- History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Subjects presenting significant medical conditions or need for long term drug therapy.
- Subjects on antibiotic, anti inflammatory or anticoagulant therapy during the month preceding the baseline exam.
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- Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations) that would interfere with the study.
- History of active severe periodontal disease with bleeding gums and loose teeth.
- Widespread caries or chronic neglect. Subjects presenting with gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, and large fractured or temporary restorations (based on visual examinations).
- Fixed or removable orthodontic appliance or removable partial dentures.
- Participation in any clinical study including dental plaque/gingivitis clinical trial involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the month preceding the start of study.
- Self reported pregnancy or lactation.
- History or current use of objects to pierce the lips or tongue.
- Subjects known to be an alcoholic, or a recovering alcoholic.
- History or current use of recreational drugs or narcotics.
- Determine smoking status of subjects and exclude current smokers.
- Determine reason for placing implants in subject to exclude subjects whose implants were placed for trauma.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
State University of New York at Buffalo
Buffalo, New York, 14260-1604
About this study
The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants
- Conditions
- Gingival Diseases
- Being tested
- Fluoride, Triclosan, fluoride
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Also called Ultrabrite toothpaste
Brush twice daily
Triclosan, fluorideDrug
Also called Total toothpaste
Brush twice daily
| Study group | Role | What they receive |
|---|---|---|
| A - | Placebo comparator | fluoride toothpaste (Ultrabrite) Receives: Drug: Fluoride |
| B - Postive control | Active comparator | fluoride/triclosan/copolymer toothpaste Receives: Drug: Triclosan, fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mombelli Plaque Index (mPI) for Natural Teeth
Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Measured: 3 months
Mombelli Plaque Index (mPI) for Natural Teeth
Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Measured: 6 months
Mombelli Plaque Index (mPI) for Dental Implants
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Measured: 3 months
Mombelli Plaque Index (mPI) for Dental Implants
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque,
1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Measured: 6 months
Löe-Silness Gingival Index Score (GI) - Natural Teeth
Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Measured: 3 months
Löe-Silness Gingival Index Score (GI) - Natural Teeth
Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Measured: 6 months
Löe-Silness Gingival Index Score (GI)- Dental Implants
Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Measured: 3 months
Löe-Silness Gingival Index Score (GI)- Dental Implants
Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Measured: 6 months
Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture \& color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.
Measured: 3 months
Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture \& color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.
Measured: 6 months
Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
Measured: 3 months
Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
Measured: 6 months
A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).
Measured: 3 months
A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
Measured: 6 months
A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
Measured: 3 months
A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
Measured: 6 months
C.Rectus (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
C.Rectus (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
C.Rectus (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
C.Rectus (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
E.Corrodens (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
E.Corrodens (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
E.Corrodens (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
Measured: 3 months
E.Corrodens (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
E.Saburreum (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
E.Saburreum (DNA Probe Analysis)- Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
E.Saburreum (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
E.Saburreum (DNA Probe Analysis) - Dental Implant
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
F.Nucleatum (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
F.Nucleatum (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
Measured: 6 months
F.Nucleatum (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
F.Nucleatum (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Neissera sp. (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Neissera sp. (DNA Probe Analysis) Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Neissera sp. (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Neissera sp. (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
P.Gingivalis (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
Measured: 3 months
P.Gingivalis (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)
Measured: 6 months
P.Gingivalis (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
Measured: 3 months
P.Gingivalis (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
Measured: 6 months
P.Intermedia (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
P.Intermedia (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
P.Intermedia (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
P.Intermedia (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
P.Melaninogenica (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
P.Melaninogenica (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).
Measured: 6 months
Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Streptococci (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Measured: 3 months
Streptococci (DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Streptococci (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Measured: 3 months
Streptococci (DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Measured: 6 months
T.Forsythia (DNA Probe Analysis)- Natural Teeth
14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
T.Forsythia (DNA Probe Analysis)-Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
T.Forsythia (DNA Probe Analysis)- Dental Implants
14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 3 months
T.Forsythia (DNA Probe Analysis)- Dental Implants
14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Measured: 6 months
Veillonella sp.(DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Measured: 3 months
Veillonella sp.(DNA Probe Analysis) - Natural Teeth
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).
Measured: 6 months
Veillonella sp.(DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Measured: 3 months
Veillonella sp.(DNA Probe Analysis) - Dental Implants
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathan Mann, MSc, Principal investigatorJoseph J Zambon, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762619
- Sponsor's protocol ID
- CRO-2007-IMPLANT-PS
- Status last verified
- Jan 2011
- First submitted
- 26 Sep 2008
- Last updated
- 25 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Examine Brushing on Dental Implants
- ClinicalTrials.gov ID
- NCT00762619
- Acronym / sponsor ID
- CRO-2007-IMPLANT-PS
- Conditions
- Gingival Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - | Placebo comparator | Drug: Fluoridefluoride toothpaste (Ultrabrite) |
| B - Postive control | Active comparator | Drug: Triclosan, fluoridefluoride/triclosan/copolymer toothpaste |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females in good oral and general health aged 18 to 76 years.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study.
- Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
- Adequate oral hygiene and no signs of oral neglect.
Key exclusion criteria (17 listed)
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
- Regular use of mouthwash with antimicrobial agents within the past month.
- History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Subjects presenting significant medical conditions or need for long term drug therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluorideAlso: Ultrabrite toothpasteBrush twice daily | Drug | A - |
| Triclosan, fluorideAlso: Total toothpasteBrush twice daily | Drug | B - Postive control |
Primary outcome
Mombelli Plaque Index (mPI) for Natural Teeth
Time frame: 3 months
Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Mombelli Plaque Index (mPI) for Natural Teeth
Time frame: 6 months
Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Mombelli Plaque Index (mPI) for Dental Implants
Time frame: 3 months
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Mombelli Plaque Index (mPI) for Dental Implants
Time frame: 6 months
Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth.
Löe-Silness Gingival Index Score (GI) - Natural Teeth
Time frame: 3 months
Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Löe-Silness Gingival Index Score (GI) - Natural Teeth
Time frame: 6 months
Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Löe-Silness Gingival Index Score (GI)- Dental Implants
Time frame: 3 months
Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Löe-Silness Gingival Index Score (GI)- Dental Implants
Time frame: 6 months
Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema \& hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores \& dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded.
Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
Time frame: 3 months
Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture \& color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema.
Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth
Time frame: 6 months
Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture \& color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema.
Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
Time frame: 3 months
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants
Time frame: 6 months
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding.
A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM).
A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM).
C.Rectus (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
C.Rectus (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
C.Rectus (DNA Probe Analysis) - Dental Implant
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
C.Rectus (DNA Probe Analysis) - Dental Implant
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Dental Implant
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Corrodens (DNA Probe Analysis) - Dental Implant
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis)- Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis) - Dental Implant
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
E.Saburreum (DNA Probe Analysis) - Dental Implant
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
F.Nucleatum (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
F.Nucleatum (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
F.Nucleatum (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
F.Nucleatum (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Neissera sp. (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Gingivalis (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
P.Gingivalis (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM)
P.Gingivalis (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
P.Gingivalis (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM)
P.Intermedia (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Intermedia (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Intermedia (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Intermedia (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
P.Melaninogenica (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Streptococci (DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Streptococci (DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Streptococci (DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
Streptococci (DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM).
T.Forsythia (DNA Probe Analysis)- Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
T.Forsythia (DNA Probe Analysis)-Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
T.Forsythia (DNA Probe Analysis)- Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
T.Forsythia (DNA Probe Analysis)- Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM).
Veillonella sp.(DNA Probe Analysis) - Natural Teeth
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Veillonella sp.(DNA Probe Analysis) - Natural Teeth
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM).
Veillonella sp.(DNA Probe Analysis) - Dental Implants
Time frame: 3 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Veillonella sp.(DNA Probe Analysis) - Dental Implants
Time frame: 6 months
14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Mann, MSc principal investigator
Joseph J Zambon, DDS principal investigator
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride and Triclosan, fluoride in people with Gingival Diseases, run by Colgate Palmolive at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mombelli Plaque Index (mPI) for Natural Teeth (time frame: 3 months). The study lists 68 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.