Dental Plaque and GingivitisPhase 2NCT02243046

The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

A Phase 2 study testing Experimental toothpaste and Active Comparator in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Dominican Republic.

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

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis. 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 and Gingivitis
What is being tested?: Experimental toothpaste and Active Comparator
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 162 participants
Where: 1 siteDominican Republic
Study dates: Dec 2014to May 2015
Phase: Phase 2
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 of the 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 period 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.
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 that 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.

Dominican Republic1 site

Spa Dental
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

Conditions: Dental Plaque and Gingivitis
Being tested: Control toothpaste, Experimental toothpaste, Active Comparator
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.

Control toothpasteDrug
Also called Max Fresh toothpaste
1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Experimental toothpasteDrug
1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Active ComparatorDrug
Also called Total toothpaste
1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Study groups in NCT02243046
Study group	Role	What they receive
Control toothpaste	Placebo comparator	1450 ppm Fluoride toothpaste Receives: Drug: Control toothpaste
Experimental toothpaste	Experimental	1450 ppm sodium fluoride toothpaste with a zinc base Receives: Drug: Experimental toothpaste
Active comparator	Active comparator	1450 ppm sodium fluoride/triclosan toothpaste Receives: Drug: Active Comparator

What is being measured

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

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 months (from 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: 6 months (from 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: 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: 3 months (from 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: 6 months (from Baseline)

Timeline

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

Dec 2014May 2015

First posted17 Sep 2014 (estimated)
Study startDec 2014
Primary completionMay 2015
Study completionMay 2015

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 Plaque and GingivitisStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02243046
Sponsor's protocol ID: CRO-2014-11-PG-ZNPTCN-ED
Status last verified: Jul 2015
First submitted: 16 Sep 2014
Last updated: 25 Feb 2019
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
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
Not yet recruitingPhase 3
Clinical Study Examining the Control of Plaque and Gingivitis
Gingivitis
RecruitingPhase 3
Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
Plaque, Dental Plaque

All Dental Plaque and Gingivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.
ClinicalTrials.gov ID: NCT02243046
Acronym / sponsor ID: CRO-2014-11-PG-ZNPTCN-ED
Conditions: Dental Plaque and Gingivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 4 May 2016

Clinical summary

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

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

Study design

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

Arm	Type	Receives
Control toothpaste	Placebo comparator	Drug: Control toothpaste1450 ppm Fluoride toothpaste
Experimental toothpaste	Experimental	Drug: Experimental toothpaste1450 ppm sodium fluoride toothpaste with a zinc base
Active comparator	Active comparator	Drug: Active Comparator1450 ppm sodium fluoride/triclosan toothpaste

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 of the 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
Control toothpasteAlso: Max Fresh toothpaste1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	Drug	Control toothpaste
Experimental toothpaste1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	Drug	Experimental toothpaste
Active ComparatorAlso: Total toothpaste1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.	Drug	Active comparator

Primary outcome

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 months (from 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: 6 months (from 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)
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: 3 months (from 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: 6 months (from 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)

Results and safety

Results posted to the registry on 4 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Toothpaste	55	54
Experimental Toothpaste	54	53
Active Comparator	53	49

Primary outcome: Gingivitis Scores

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

Measure	Control Toothpaste n = 55	Experimental Toothpaste n = 54	Active Comparator n = 53
Value	1.48 (0.23)	1.57 (0.28)	1.49 (0.20)

Control Toothpaste vs Experimental Toothpaste vs Active Comparator: p = 0.091, ANOVA

Primary outcome: Gingivitis Scores

Time frame: 3 months (from Baseline). Mean (Standard Deviation). Unit: units on a scale

Measure	Control Toothpaste n = 54	Experimental Toothpaste n = 53	Active Comparator n = 51
Value	1.46 (0.19)	1.33 (0.23)	1.25 (0.18)

Control Toothpaste vs Experimental Toothpaste vs Active Comparator: p <0.001, ANCOVA

Primary outcome: Gingivitis Scores

Time frame: 6 months (from Baseline). Mean (Standard Deviation). Unit: units on a scale

Measure	Control Toothpaste n = 54	Experimental Toothpaste n = 53	Active Comparator n = 49
Value	1.44 (0.20)	1.23 (0.23)	1.19 (0.17)

Control Toothpaste vs Experimental Toothpaste vs Active Comparator: p < 0.001, ANCOVA

Primary outcome: Dental Plaque Scores

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

Measure	Control Toothpaste n = 55	Experimental Toothpaste n = 54	Active Comparator n = 53
Value	2.91 (0.24)	2.95 (0.29)	2.90 (0.20)

Control Toothpaste vs Experimental Toothpaste vs Active Comparator: p = 0.571, ANOVA

Adverse events

Time frame: Baseline, 3 and 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Toothpaste	0 of 55 (0%)	0 of 55 (0%)	Not reported
Experimental Toothpaste	0 of 54 (0%)	0 of 54 (0%)	Not reported
Active Comparator	0 of 53 (0%)	0 of 53 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Plaque and Gingivitis

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
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
Not yet recruitingPhase 3
Clinical Study Examining the Control of Plaque and Gingivitis
Gingivitis
RecruitingPhase 3
Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
Plaque, Dental Plaque

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?

A Phase 2 study testing Experimental toothpaste and Active Comparator in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in Dominican Republic.

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 25 Feb 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 Dominican Republic. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 May 2016). 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?

Gingivitis 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 NCT02243046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.