Dental PlaquePhase 3NCT02193165

The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

A Phase 3 study testing triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash, stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash and fluoride toothpaste + fluoride Mouthwash in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Puerto Rico.

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

The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis. Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Dental Plaque, Gingivitis
What is being tested?: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash, stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash and fluoride toothpaste + fluoride Mouthwash
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 sitePuerto Rico
Study dates: Jul 2014to Aug 2014
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 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and female subjects, ages 21-70, inclusive.
Availability for the six-week duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Who cannot join

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.

Show all 13Show fewer

Participation in any other clinical study or test panel within the one month prior to entry into the study.
Pregnant women or women who are breast feeding.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse

Trial locations and contacts

1 site in 1 country.

Puerto Rico1 site

Centro Comercial Plaza Trujillo
Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis.

Conditions: Dental Plaque, Gingivitis
Being tested: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash, stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash, fluoride toothpaste + fluoride Mouthwash
Medical subject headings: Dental Plaque, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

triclosan/fluoride toothpaste + cetylpyridinium chloride MouthwashDrug
Also called Total toothpaste, Total Mouthwash
Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
stannous fluoride toothpaste + cetylpyridinium chloride MouthwashDrug
Also called Crest Pro-Health toothpaste, Crest Pro-Health Multi-Protection Mouthwash
Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
fluoride toothpaste + fluoride MouthwashDrug
Also called Crest Cavity Protection toothpaste, Crest Pro-Health For Me Breezy Mint mouthwash
Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Study groups in NCT02193165
Study group	Role	What they receive
Regimen 1	Active comparator	triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash Receives: Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
Regimen 2	Active comparator	stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash Receives: Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Regimen 3 - Control group	Placebo comparator	fluoride toothpaste + fluoride Mouthwash Receives: Drug: fluoride toothpaste + fluoride Mouthwash

What is being measured

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

Dental Plaque Scores
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Measured: Baseline
Dental Plaque Scores
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Measured: 4 weeks
Dental Plaque Scores
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Measured: 6 weeks
Gingivitis Scores
Gingivitis scale (Loe \& Silness Gingival Index) 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)
Measured: Baseline
Gingivitis Scores
Gingivitis scale (Loe \& Silness Gingival Index) 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)
Measured: 4 weeks
Gingivitis Scores
Gingivitis scale (Loe \& Silness Gingival Index) 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)
Measured: 6 weeks

Timeline

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

Jul 2014Aug 2014

First posted17 Jul 2014 (estimated)
Study startJul 2014
Primary completionAug 2014
Study completionAug 2014

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 Dental PlaqueStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02193165
Sponsor's protocol ID: CRO-2014-07-PG-REG-PR-BS
Status last verified: Jul 2015
First submitted: 15 Jul 2014
Last updated: 17 Aug 2015
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

Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis

All Dental Plaque trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis.
ClinicalTrials.gov ID: NCT02193165
Acronym / sponsor ID: CRO-2014-07-PG-REG-PR-BS
Conditions: Dental Plaque, Gingivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 17 Jul 2014 (estimated)
Results: Posted 6 Feb 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
Regimen 1	Active comparator	Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwashtriclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
Regimen 2	Active comparator	Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwashstannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Regimen 3 - Control group	Placebo comparator	Drug: fluoride toothpaste + fluoride Mouthwashfluoride toothpaste + fluoride Mouthwash

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male and female subjects, ages 21-70, inclusive.
Availability for the six-week duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.

Key exclusion criteria (13 listed)

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.

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
triclosan/fluoride toothpaste + cetylpyridinium chloride MouthwashAlso: Total toothpaste, Total MouthwashBrush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.	Drug	Regimen 1
stannous fluoride toothpaste + cetylpyridinium chloride MouthwashAlso: Crest Pro-Health toothpaste, Crest Pro-Health Multi-Protection MouthwashBrush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.	Drug	Regimen 2
fluoride toothpaste + fluoride MouthwashAlso: Crest Cavity Protection toothpaste, Crest Pro-Health For Me Breezy Mint mouthwashBrush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.	Drug	Regimen 3 - Control group

Primary outcome

Dental Plaque Scores
Time frame: Baseline
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Dental Plaque Scores
Time frame: 4 weeks
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Dental Plaque Scores
Time frame: 6 weeks
Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)
Gingivitis Scores
Time frame: Baseline
Gingivitis scale (Loe \& Silness Gingival Index) 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)
Gingivitis Scores
Time frame: 4 weeks
Gingivitis scale (Loe \& Silness Gingival Index) 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)
Gingivitis Scores
Time frame: 6 weeks
Gingivitis scale (Loe \& Silness Gingival Index) 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)

Results and safety

Results posted to the registry on 6 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regimen 1	40	39
Regimen 2	40	39
Regimen 3 - Control Group	40	39

Primary outcome: Dental Plaque Scores

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Regimen 1 n = 40	Regimen 2 n = 40	Regimen 3 - Control Group n = 40
Value	3.33 (0.52)	3.19 (0.53)	3.31 (0.48)

Regimen 1 vs Regimen 2 vs Regimen 3 - Control Group: p = 0.434, ANOVA

Primary outcome: Dental Plaque Scores

Time frame: 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Regimen 1 n = 39	Regimen 2 n = 39	Regimen 3 - Control Group n = 39
Value	2.78 (0.56)	2.79 (0.52)	3.34 (0.48)

Regimen 2 vs Regimen 3 - Control Group: p <0.001, ANCOVA

Primary outcome: Dental Plaque Scores

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

Measure	Regimen 1 n = 39	Regimen 2 n = 38	Regimen 3 - Control Group n = 39
Value	2.42 (0.62)	2.59 (0.58)	3.38 (0.49)

Regimen 1 vs Regimen 2 vs Regimen 3 - Control Group: p <0.001, ANCOVA

Primary outcome: Gingivitis Scores

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Regimen 1 n = 40	Regimen 2 n = 40	Regimen 3 - Control Group n = 40
Value	1.40 (0.31)	1.40 (0.32)	1.44 (0.37)

Regimen 1 vs Regimen 2 vs Regimen 3 - Control Group: p = 0.816, ANOVA

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen 1	0 of 40 (0%)	0 of 40 (0%)	Not reported
Regimen 2	0 of 40 (0%)	0 of 40 (0%)	Not reported
Regimen 3 - Control Group	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Plaque

Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 13 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 Aug 2015. 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 Puerto Rico. 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 6 Feb 2015). 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 Scores (time frame: Baseline). The study lists 6 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 NCT02193165.

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 Aug 2015.