NCT03546491

Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Completed Phase 3 Results posted Last updated 4 September 2019

What this trial tests

Phase 3 trial testing Preventive Gel in Dental Plaque in 32 participants. Completed in 22 June 2018.

Timeline

8 May 2018

Primary endpoint
22 June 2018

22 June 2018

Quick facts

Lead sponsor	Procter and Gamble
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	prevention
Enrollment	32
Start date	8 May 2018
Primary completion	22 June 2018
Estimated completion	22 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Preventive Gel — full drug profile →
• Marketed Control — full drug profile →

Conditions studied

• Dental Plaque — all drugs for Dental Plaque →

Sponsor

Procter and Gamble — full company profile →

Who can join

18 and older, any sex, with Dental Plaque. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Turesky Modified Quigley-Hein Index at Day 4 Primary · 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

Group	Value	95% CI
Preventive Gel	1.83	± 0.055
Marketed Control	1.96	± 0.055

Mean Turesky Modified Quigley-Hein Index at Baseline Secondary · 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

Group	Value	95% CI
Preventive Gel	2.19	± 0.07
Marketed Control	2.22	± 0.07

Digital Plaque Imaging Secondary · Day 4

Total percent dental plaque area

Group	Value	95% CI
Preventive Gel	8.14	± 0.871
Marketed Control	10.95	± 0.871

Overall Baseline Mean Digital Plaque Imaging Secondary · Baseline

Total percent dental plaque area

Group	Value	95% CI
Preventive Gel	6.57	± 1.18
Marketed Control	7.29	± 1.18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for the entire duration of the study for each intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preventive Gel

Serious: 0/32 (0%)

Deaths: 0/32

Marketed Control

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (5 terms — click to expand)

Reaction	System	Preventive Gel	Marketed Control
Irritation Mouth	Gastrointestinal disorders	—	—
Irritation Gum	Gastrointestinal disorders	—	—
Irritation Lip	Gastrointestinal disorders	—	—
Desquamation Oral	Gastrointestinal disorders	—	—
Herpetic Lesion Oral	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03546491 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.