Dental PlaquePhase 4NCT02080273

Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste

A Phase 4 study testing Colgate Cavity Protection toothpaste, Colgate Total toothpaste and Parodontax toothpaste in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Thailand.

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 randomized, single center, parallel clinical research study is to evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste, Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and dental plaque in adults. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Dental Plaque, Gingivitis
What is being tested?: Colgate Cavity Protection toothpaste, Colgate Total toothpaste and Parodontax toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 1 siteThailand
Study dates: Mar 2013to Nov 2013
Phase: Phase 4
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe clinical research 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.
Antibiotic use any time during the one month prior to entry into the study.

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Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during 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.
Pregnant or lactating subjects.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Mahidol University
Ratchathewi, Bangkok, 10400

Other trials in Thailand

About this study

Official title: The Clinical Investigation of Colgate Total Toothpaste as Compared to Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis. (A Six Month Study)

Conditions: Dental Plaque, Gingivitis
Being tested: Colgate Cavity Protection toothpaste, Colgate Total toothpaste, Parodontax toothpaste
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.

Colgate Cavity Protection toothpasteDrug
0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
Colgate Total toothpasteDrug
0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
Parodontax toothpasteDrug
1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste

Study groups in NCT02080273
Study group	Role	What they receive
Colgate Cavity Protection toothpaste	Placebo comparator	Brush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland Receives: Drug: Colgate Cavity Protection toothpaste
Colgate Total toothpaste	Active comparator	Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland Receives: Drug: Colgate Total toothpaste
Parodontax	Active comparator	Brush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland. Receives: Drug: Parodontax toothpaste

What is being measured

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

Dental Plaque Score
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 Score
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: 3 weeks post treatment use
Dental Plaque Score
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: 3 months post treatment use
Dental Plaque Score
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 months post treatment use
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: 3 weeks post treatment use
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: 3 months post treatment use
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 months post treatment use

Timeline

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

Mar 2013Nov 2013

First posted6 Mar 2014 (estimated)
Study startMar 2013
Primary completionNov 2013
Study completionNov 2013

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dental PlaqueStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02080273
Sponsor's protocol ID: CRO-2012-10-CT-BKK-YPZ
Status last verified: Mar 2014
First submitted: 4 Mar 2014
Last updated: 20 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Triratana T, Kraivaphan P, Amornchat C, Mateo LR, Morrison BM Jr, Dibart S, Zhang YP. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study. Am J Dent. 2015 Apr;28(2):68-74.
PubMed 26087570

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

Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
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Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
Recruiting
A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
Dental Plaque, Gingivitis

All Dental Plaque trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Investigation of Colgate Total Toothpaste as Compared to Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis. (A Six Month Study)
ClinicalTrials.gov ID: NCT02080273
Acronym / sponsor ID: CRO-2012-10-CT-BKK-YPZ
Conditions: Dental Plaque, Gingivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Collaborators: Mahidol University
Study start: Mar 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 6 Mar 2014 (estimated)
Results: Posted 20 May 2019

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
Colgate Cavity Protection toothpaste	Placebo comparator	Drug: Colgate Cavity Protection toothpasteBrush whole mouth 2x/day with Colgate Cavity Protection toothpaste. This study treatment is currently marketed/sold in Poland
Colgate Total toothpaste	Active comparator	Drug: Colgate Total toothpasteBrush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland
Parodontax	Active comparator	Drug: Parodontax toothpasteBrush whole mouth 2x/day with Parodontax toothpaste. This study treatment is currently marketed/sold in Poland.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe clinical research 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
Colgate Cavity Protection toothpaste0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.	Drug	Colgate Cavity Protection toothpaste
Colgate Total toothpaste0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste	Drug	Colgate Total toothpaste
Parodontax toothpaste1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste	Drug	Parodontax

Primary outcome

Dental Plaque Score
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 Score
Time frame: 3 weeks post treatment use
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 Score
Time frame: 3 months post treatment use
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 Score
Time frame: 6 months post treatment use
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: 3 weeks post treatment use
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: 3 months post treatment use
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 months post treatment use
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 20 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colgate Cavity Protection Toothpaste	45	45
Colgate Total Toothpaste	45	45
Parodontax	45	45

Primary outcome: Dental Plaque Score

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

Measure	Colgate Cavity Protection Toothpaste n = 45	Colgate Total Toothpaste n = 45	Parodontax n = 45
Value	3.53 (0.37)	3.55 (0.36)	3.59 (0.36)

Colgate Cavity Protection Toothpaste vs Colgate Total Toothpaste vs Parodontax: p = 0.919, ANOVA

Primary outcome: Dental Plaque Score

Time frame: 3 weeks post treatment use. Mean (Standard Deviation). Unit: units on a scale

Measure	Colgate Cavity Protection Toothpaste n = 45	Colgate Total Toothpaste n = 45	Parodontax n = 45
Value	3.46 (0.15)	2.98 (0.37)	3.50 (0.25)

Colgate Cavity Protection Toothpaste vs Colgate Total Toothpaste vs Parodontax: p = 0.001, ANCOVA

Primary outcome: Dental Plaque Score

Time frame: 3 months post treatment use. Mean (Standard Deviation). Unit: units on a scale

Measure	Colgate Cavity Protection Toothpaste n = 45	Colgate Total Toothpaste n = 45	Parodontax n = 45
Value	3.31 (0.42)	2.45 (0.29)	3.45 (0.42)

Colgate Cavity Protection Toothpaste vs Colgate Total Toothpaste vs Parodontax: p = 0.001, ANCOVA

Primary outcome: Dental Plaque Score

Time frame: 6 months post treatment use. Mean (Standard Deviation). Unit: units on a scale

Measure	Colgate Cavity Protection Toothpaste n = 45	Colgate Total Toothpaste n = 45	Parodontax n = 45
Value	3.40 (0.39)	1.65 (0.45)	3.23 (0.35)

Colgate Cavity Protection Toothpaste vs Colgate Total Toothpaste vs Parodontax: p = 0.001, ANCOVA

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Colgate Cavity Protection Toothpaste	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Colgate Total Toothpaste	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Parodontax	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26087570Triratana T, Kraivaphan P, Amornchat C, Mateo LR, Morrison BM Jr, Dibart S, Zhang YP. Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study. Am J Dent. 2015 Apr;28(2):68-74.

Related trials for Dental Plaque

Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
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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.

Terdphong Triratana principal investigator

Mahidol University

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 20 May 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 May 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?

Dental Plaque Score (time frame: baseline). The study lists 8 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 NCT02080273, which also lists 1 linked publication.

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 20 May 2019.