Dental PlaquePhase 3NCT03546491

Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

A Phase 3 study testing Preventive Gel in people with Dental Plaque, run by Procter and Gamble 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

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Plaque
What is being tested?: Preventive Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 8 May 2018to 22 Jun 2018
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
Be 18 years of age or older;
Agree not to participate in any other oral/dental product studies during the study;
Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
Agree to use an oral hygiene product that contains stannous fluoride;

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Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
Agree to return for all scheduled visits and follow study procedures;
Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;
Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
Have previously demonstrated an inability to comply with study visit requirements;
Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oral Health Science Center
Mason, Ohio, 45040

Other trials in United States

About this study

Official title: A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Conditions: Dental Plaque
Being tested: Preventive Gel, Marketed Control
Medical subject headings: Dental Plaque

What participants receive

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

Preventive GelDrug
0.4% Stannous Fluoride
Marketed ControlDrug
0.243% Sodium Fluoride

Study groups in NCT03546491
Study group	Role	What they receive
Preventive Gel	Experimental	0.4% stannous fluoride Receives: Drug: Preventive Gel
Marketed Control	Active comparator	0.243 % Sodium Fluoride Receives: Drug: Marketed Control

What is being measured

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

Mean Turesky Modified Quigley-Hein Index at Day 4
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Measured: Day 4

Secondary outcomes (3)

Mean Turesky Modified Quigley-Hein Index at Baseline
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Measured: Baseline
Digital Plaque Imaging
Total percent dental plaque area
Measured: Day 4
Overall Baseline Mean Digital Plaque Imaging
Total percent dental plaque area
Measured: Baseline

Timeline

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

8 May 201822 Jun 2018

First posted6 Jun 2018
Study start8 May 2018
Primary completion22 Jun 2018
Study completion22 Jun 2018

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.
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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03546491
Sponsor's protocol ID: 2018009
Status last verified: Aug 2019
First submitted: 23 May 2018
Last updated: 4 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
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A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
Dental Plaque, Gingivitis
Not yet recruitingPhase 2/3
Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash
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All Dental Plaque trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model
ClinicalTrials.gov ID: NCT03546491
Acronym / sponsor ID: 2018009
Conditions: Dental Plaque
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Procter and GambleIndustry (pharma, biotech, devices)
Study start: 8 May 2018 (actual)
Primary completion: 22 Jun 2018 (actual)
Study completion: 22 Jun 2018 (actual)
First posted: 6 Jun 2018 (actual)
Results: Posted 4 Sep 2019

Clinical summary

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

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Preventive Gel	Experimental	Drug: Preventive Gel0.4% stannous fluoride
Marketed Control	Active comparator	Drug: Marketed Control0.243 % Sodium Fluoride

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
Be 18 years of age or older;
Agree not to participate in any other oral/dental product studies during the study;
Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);

Key exclusion criteria (0 listed)

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
Preventive Gel0.4% Stannous Fluoride	Drug	Preventive Gel
Marketed Control0.243% Sodium Fluoride	Drug	Marketed Control

Primary outcome

Mean Turesky Modified Quigley-Hein Index at Day 4
Time frame: Day 4
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.

3 secondary outcomes

Mean Turesky Modified Quigley-Hein Index at Baseline
Time frame: Baseline
Digital Plaque Imaging
Time frame: Day 4
Overall Baseline Mean Digital Plaque Imaging
Time frame: Baseline

Results and safety

Results posted to the registry on 4 Sep 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
Overall Study	32	30

Primary outcome: Mean Turesky Modified Quigley-Hein Index at Day 4

Time frame: Day 4. Mean (Standard Error). Unit: score on a scale

Measure	Preventive Gel n = 32	Marketed Control n = 32
Value	1.83 (0.055)	1.96 (0.055)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the entire duration of the study for each intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Preventive Gel	0 of 32 (0%)	8 of 32 (25%)	0 of 32
Marketed Control	0 of 32 (0%)	6 of 32 (18.8%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Plaque

Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
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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Recruiting
A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride
Dental Plaque, Gingivitis
Not yet recruitingPhase 2/3
Anticariogenic Effect of Moringa Oleifera Mouthwash Compared to Chlorhexidine Mouthwash
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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.

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 3 study testing Preventive Gel in people with Dental Plaque, run by Procter and Gamble 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 18 inclusion and 0 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 4 Sep 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. 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 4 Sep 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?

Mean Turesky Modified Quigley-Hein Index at Day 4 (time frame: Day 4). 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 NCT03546491.

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 4 Sep 2019; AzTrials last refreshed its copy on 26 Oct 2026.