GingivitisNCT01419626
A Study to Determine the Effects of Adding an Experimental Device With Mouthrinse to Oral Care Regimen
A study testing Interdental cleaning device with water and Interdental cleaning device with essential-oil mouthrinse in people with Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Interdental cleaning device with water and Interdental cleaning device with essential-oil mouthrinse
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2011to 31 Aug 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
- Able to provide written informed consent; volunteers must read, sign, and receive a copy of the signed Informed Consent Form after the nature of the study has been fully explained.
- Males and females 18 years of age or older, in good general and oral health, except gingivitis.
- A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
- A gingival index ≥ 1.75 according to the Modified Gingival Index.
- A plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
Show all 12Show fewer
- Gingival Bleeding Index ≥ 0.1.
- Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
- Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
- Absence of fixed or removable orthodontic appliance or removable partial dentures.
- Are willing and able to fully understand and comply with the written and verbal study instructions provided in English
- Agree to return all study materials at the final visit (week 4).
Who cannot join
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
- History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject, such as having have a cardiac pacemaker or AICD.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
- Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
- Current or history of alcohol or drug abuse, and those who smoke more than one pack of cigarettes per day
Show all 14Show fewer
- Females who are pregnant or breastfeeding.
- Known sensitivity to the investigational product.
- Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study.
- Participation in any clinical study within 30 days of Visit 1.
- Relative, partner or staff of any clinical research site personnel.
- A member of the same household (i.e. residing in the same house) is a participant in this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Are employed by an oral healthcare products company or dental research institution (i.e., dental school: administrative staff, assistants, hygienists, and research students).
Trial locations and contacts
1 site in 1 country.
United States1 site
BioSci Research America, Inc
Las Vegas, Nevada, 89121
About this study
Official title: Antiplaque and Antigingivitis Efficacy of Interdental Cleaning Using an Experimental Device in Combination With an Essential-oil Containing Mouthrinse
The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. They will be asked to follow their assigned oral care regimen, fill out subject diaries as instructed, and return to the clinic two weeks and four weeks afterward to have their mouths examined.
Read the detailed description
At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral exam, plaque, gingivitis and gingival bleeding assessments) having refrained from oral hygiene for at least 12 hours, but no more than 18 hours and from eating for at least 2 hours prior to that examination. After the baseline oral examinations, and assessment of other inclusion/exclusion criteria, qualifying subjects will be randomly assigned to one of the three treatment groups. Immediately following this randomization, all subjects will begin their regimen of brushing with a manual toothbrush while two of the groups will also receive an experimental interdental cleaning device to use either with water or with an assigned mouthrinse following the label instructions described on the experimental device label. Subjects who are assigned to the negative control group will use the manual toothbrush and provided toothpaste as their sole mean of oral hygiene. Subjects assigned to the Device-only control group will brush with a manual toothbrush and use the Experimental Interdental Cleaning Device with water. Finally, those subjects randomized to the test group will brush with a manual toothbrush and use the experimental interdental cleaning device in combination with a marketed antiseptic mouthrinse.
Subjects will brush twice-a-day and if assigned, will use the experimental interdental cleaning device once-a-day for 4 weeks, post-brushing, according to instructions given by the study personnel. The first oral hygiene procedure will be conducted under supervision of study personnel at the research site. All other study material usage will be unsupervised and the subjects will be required to maintain a Diary Card to document daily oral hygiene routine. Compliance will be evaluated at each visit by reviewing the subject diaries and, when applicable, by weighing residual volumes of returned mouthrinse.
Subjects will refrain from the use of any interdental cleaning device, unless assigned by the randomization schedule (i.e., not to use dental floss, toothpick, etc), unless it is used to remove impacted food between the teeth, during the course of the study. No other oral hygiene procedures will be permitted, including teeth cleaning or dental work except for an emergency.
At the two and four-week visits, the Modified Gingival Index (MGI), the Bleeding Index (BI) and the Turesky modification of the Quigley-Hein Plaque Index (PI) will be scored and the oral tissue examinations performed. At the two and four-week visits, subjects will not have used their test materials for at least 12 hours, but no more than 18 hours.
- Conditions
- Gingivitis
- Being tested
- Interdental cleaning device with water, Interdental cleaning device with essential-oil mouthrinse
- Keywords
- Dental Plaque, Interdental Cleaning Device
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental cleaning device with waterDevice
Also called Regulation # 872.6510 with water
Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
Interdental cleaning device with essential-oil mouthrinseDevice
Also called Regulation # 872.6510 with Mouthrinse # 19292-116A
Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | No intervention | Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste. |
| Device with Water | Sham comparator | Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. Receives: Device: Interdental cleaning device with water |
| Device with Mouthrinse | Experimental | Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. Receives: Device: Interdental cleaning device with essential-oil mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interproximal Mean Plaque Index at Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Measured: Week 4
Whole-mouth Mean Plaque Index at Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Measured: Week 4
Secondary outcomes (6)
Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: Week 2 and 4
Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4
Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: Week 2 and 4
Interproximal Mean Plaque Index (Mean PI) at Week 2
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Measured: Week 2
Whole-mouth Mean Plaque Index (Mean PI) at Week 2
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Measured: Week 2
Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Measured: Week 2 and 4
Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4
Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.
Measured: Week 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study start31 Jul 2011
- Primary completion31 Aug 2011
- Study completion31 Aug 2011
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 GingivitisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo WB Araujo, DDS,MS,PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419626
- Sponsor's protocol ID
- UNKPLT0008
- Status last verified
- Nov 2019
- First submitted
- 17 Aug 2011
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplaque and Antigingivitis Efficacy of Interdental Cleaning Using an Experimental Device in Combination With an Essential-oil Containing Mouthrinse
- ClinicalTrials.gov ID
- NCT01419626
- Acronym / sponsor ID
- UNKPLT0008
- Conditions
- Gingivitis
- Keywords
- Dental Plaque, Interdental Cleaning Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2011 (actual)
- Primary completion
- 31 Aug 2011 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will determine the effects of adding mechanical plaque control to a person's oral care regimen. Participants who qualify to participate in the study will will have an equal chance of being assigned to one of three groups. They will be asked to follow their assigned oral care regimen, fill out subject diaries as instructed, and return to the clinic two weeks and four weeks afterward to have their mouths examined.
Detailed description
At baseline, the prescreened subjects will present to the clinical site for baseline examinations (oral exam, plaque, gingivitis and gingival bleeding assessments) having refrained from oral hygiene for at least 12 hours, but no more than 18 hours and from eating for at least 2 hours prior to that examination. After the baseline oral examinations, and assessment of other inclusion/exclusion criteria, qualifying subjects will be randomly assigned to one of the three treatment groups. Immediately following this randomization, all subjects will begin their regimen of brushing with a manual toothbrush while two of the groups will also receive an experimental interdental cleaning device to use either with water or with an assigned mouthrinse following the label instructions described on the experimental device label. Subjects who are assigned to the negative control group will use the manual toothbrush and provided toothpaste as their sole mean of oral hygiene. Subjects assigned to the Device-only control group will brush with a manual toothbrush and use the Experimental Interdental Cleaning Device with water. Finally, those subjects randomized to the test group will brush with a manual toothbrush and use the experimental interdental cleaning device in combination with a marketed antiseptic mouthrinse.
Subjects will brush twice-a-day and if assigned, will use the experimental interdental cleaning device once-a-day for 4 weeks, post-brushing, according to instructions given by the study personnel. The first oral hygiene procedure will be conducted under supervision of study personnel at the research site. All other study material usage will be unsupervised and the subjects will be required to maintain a Diary Card to document daily oral hygiene routine. Compliance will be evaluated at each visit by reviewing the subject diaries and, when applicable, by weighing residual volumes of returned mouthrinse.
Subjects will refrain from the use of any interdental cleaning device, unless assigned by the randomization schedule (i.e., not to use dental floss, toothpick, etc), unless it is used to remove impacted food between the teeth, during the course of the study. No other oral hygiene procedures will be permitted, including teeth cleaning or dental work except for an emergency.
At the two and four-week visits, the Modified Gingival Index (MGI), the Bleeding Index (BI) and the Turesky modification of the Quigley-Hein Plaque Index (PI) will be scored and the oral tissue examinations performed. At the two and four-week visits, subjects will not have used their test materials for at least 12 hours, but no more than 18 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control | No intervention | –Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste. |
| Device with Water | Sham comparator | Device: Interdental cleaning device with waterSubjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. |
| Device with Mouthrinse | Experimental | Device: Interdental cleaning device with essential-oil mouthrinseSubjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment.
- Able to provide written informed consent; volunteers must read, sign, and receive a copy of the signed Informed Consent Form after the nature of the study has been fully explained.
- Males and females 18 years of age or older, in good general and oral health, except gingivitis.
- A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
- A gingival index ≥ 1.75 according to the Modified Gingival Index.
Key exclusion criteria (14 listed)
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
- History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject, such as having have a cardiac pacemaker or AICD.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
- Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
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 |
|---|---|---|
| Interdental cleaning device with waterAlso: Regulation # 872.6510 with waterSubjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. | Device | Device with Water |
| Interdental cleaning device with essential-oil mouthrinseAlso: Regulation # 872.6510 with Mouthrinse # 19292-116ASubjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks. | Device | Device with Mouthrinse |
Primary outcome
Interproximal Mean Plaque Index at Week 4
Time frame: Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
Whole-mouth Mean Plaque Index at Week 4
Time frame: Week 4
Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.
6 secondary outcomes
Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4
Time frame: Week 2 and 4
Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4
Time frame: Week 2 and 4
Interproximal Mean Plaque Index (Mean PI) at Week 2
Time frame: Week 2
Whole-mouth Mean Plaque Index (Mean PI) at Week 2
Time frame: Week 2
Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4
Time frame: Week 2 and 4
Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4
Time frame: Week 2 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- 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.
Marcelo WB Araujo, DDS,MS,PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdental cleaning device with water and Interdental cleaning device with essential-oil mouthrinse in people with Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
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 12 inclusion and 14 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). 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?
Interproximal Mean Plaque Index at Week 4 (time frame: Week 4). The study lists 2 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 17 Dec 2019.