Clinical trial NCT03546491: Evaluate Dental Plaque Benefit of a Preventive Treatment Gel
Official title: A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Mean Turesky Modified Quigley-Hein Index at Day 4
timeFrame: Day 4
Secondary outcomes:
measure: Mean Turesky Modified Quigley-Hein Index at Baseline
timeFrame: Baseline
measure: Digital Plaque Imaging
timeFrame: Day 4
measure: Overall Baseline Mean Digital Plaque Imaging
timeFrame: Baseline
Other outcomes:
Locations:
city: Mason
country: United States
facility: Oral Health Science Center
state: Ohio
Study officials:
References: