Gingival DiseasesPhase 3NCT00761930

Compare the Clinical Efficacy of Prototype Toothpastes.

A Phase 3 study testing Fluoride, Triclosan and fluoride and Herbal Ingredient and fluoride in people with Gingival Diseases, run by Colgate Palmolive at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Gingival Diseases
What is being tested?: Fluoride, Triclosan and fluoride and Herbal Ingredient and fluoride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Jun 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female volunteers 18-65 years of age
Good general health
Must sign informed consent form
Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
No history of allergy to personal care consumer products, or their ingredients,
relevant to any ingredient in the test products as determined by the dental/medical

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Professional monitoring the study.
Dental Selection Criteria: Average full mouth GI score should be in the range of
- 2.0. heavy plaque formers should be avoided. Target a full mouth PI
(Quigley-Hein) to be in the range of 1.5-3.0
If of child bearing potential and on birth control (diaphragm, birth control pills,
Birth control implants, IUD (Intrauterine device), condoms)

Who cannot join

Subjects unable or unwilling to sign the informed consent form.
Medical condition which requires pre-medication prior to dental visits/procedures
Moderate or advanced periodontal disease
2 or more decayed untreated dental sites at screening.
Other disease of the hard or soft oral tissues.
Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

Show all 19Show fewer

Use of medications that are currently affect salivary flow.
Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
Pregnant or nursing women.
Participation in any other clinical study within 1 week prior to enrollment into this
study.
Use of tobacco products
Subjects who must receive dental treatment during the study dates.
Current use of Antibiotics for any purpose.
History of allergy to common dentifrice ingredients
Presence of an orthodontic appliance which interferes with plaque scoring.
History of allergy to natural remedies, such as herbal ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Smoker

Trial locations and contacts

1 site in 1 country.

United States1 site

Eastman Dental Center - University of Rochester
Rochester, New York, 14642-8315

Other trials in United States

About this study

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Conditions: Gingival Diseases
Being tested: Fluoride, Triclosan and fluoride, Herbal Ingredient and 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 Colgate Great Regular Flavor toothpaste
Brush twice daily
Triclosan and fluorideDrug
Also called Colgate Total toothpaste
Brush twice daily
Herbal Ingredient and fluorideDrug
Brush twice daily

Study groups in NCT00761930
Study group	Role	What they receive
A	Placebo comparator	commercially available Fluoride toothpaste Receives: Drug: Fluoride
B	Active comparator	fluoride/triclosan/copolymer toothpaste Receives: Drug: Triclosan and fluoride
C	Experimental	fluoride/herbal toothpaste Receives: Drug: Herbal Ingredient and fluoride

What is being measured

The primary outcome is the main question the study is designed to answer.

Dental Plaque
Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Measured: 6 weeks
Gingivitis Score
Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation,
1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Measured: 6 weeks
Bleeding Index (EIBI)
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding \& 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2008

First posted30 Sep 2008 (estimated)
Study startMar 2008
Primary completionJun 2008
Study completionJun 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.
More trials run by Colgate PalmoliveThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761930
Sponsor's protocol ID: CRO-2007-GIN-04-RR
Status last verified: Aug 2013
First submitted: 26 Sep 2008
Last updated: 15 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gingival Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compare the Clinical Efficacy of Prototype Toothpastes.
ClinicalTrials.gov ID: NCT00761930
Acronym / sponsor ID: CRO-2007-GIN-04-RR
Conditions: Gingival Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 20 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
A	Placebo comparator	Drug: Fluoridecommercially available Fluoride toothpaste
B	Active comparator	Drug: Triclosan and fluoridefluoride/triclosan/copolymer toothpaste
C	Experimental	Drug: Herbal Ingredient and fluoridefluoride/herbal toothpaste

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or female volunteers 18-65 years of age
Good general health
Must sign informed consent form
Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
No history of allergy to personal care consumer products, or their ingredients,

Key exclusion criteria (19 listed)

Subjects unable or unwilling to sign the informed consent form.
Medical condition which requires pre-medication prior to dental visits/procedures
Moderate or advanced periodontal disease
2 or more decayed untreated dental sites at screening.
Other disease of the hard or soft oral tissues.

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: Colgate Great Regular Flavor toothpasteBrush twice daily	Drug	A
Triclosan and fluorideAlso: Colgate Total toothpasteBrush twice daily	Drug	B
Herbal Ingredient and fluorideBrush twice daily	Drug	C

Primary outcome

Dental Plaque
Time frame: 6 weeks
Quigley Hein Method: Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Gingivitis Score
Time frame: 6 weeks
Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Bleeding Index (EIBI)
Time frame: 6 weeks
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding \& 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.

Results and safety

Results posted to the registry on 20 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A- Placebo Comparator	34	34
B - Active Comparator	34	34
C - Experimental Toothpaste	35	35

Primary outcome: Dental Plaque

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	A- Placebo Comparator n = 34	B - Active Comparator n = 34	C - Experimental Toothpaste n = 35
Value	2.273 (0.328)	1.806 (0.523)	2.041 (0.403)

A- Placebo Comparator vs B - Active Comparator vs C - Experimental Toothpaste: p <0.05, ANCOVA

Primary outcome: Gingivitis Score

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	A- Placebo Comparator n = 34	B - Active Comparator n = 34	C - Experimental Toothpaste n = 35
Value	0.942 (0.302)	0.722 (0.369)	0.705 (0.387)

A- Placebo Comparator vs B - Active Comparator vs C - Experimental Toothpaste: p <0.05, ANCOVA

Primary outcome: Bleeding Index (EIBI)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: Units on a scale

Measure	A- Placebo Comparator n = 34	B - Active Comparator n = 34	C - Experimental Toothpaste n = 35
Value	0.325 (.246)	0.164 (0.194)	0.141 (0.183)

A- Placebo Comparator vs B - Active Comparator vs C - Experimental Toothpaste: p <0.05, ANCOVA

Adverse events

Time frame: 7 weeks (1 week washout period + 6 week study test period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A- Placebo Comparator	0 of 34 (0%)	0 of 34 (0%)	Not reported
B - Active Comparator	0 of 34 (0%)	0 of 34 (0%)	Not reported
C - Experimental Toothpaste	0 of 35 (0%)	0 of 35 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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.

Yanfang Ren, DDS principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluoride, Triclosan and fluoride and Herbal Ingredient and fluoride in people with Gingival Diseases, run by Colgate Palmolive 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 19 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 15 Aug 2013. 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.

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 20 Oct 2010). 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?

Dental Plaque (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00761930.

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 15 Aug 2013.