Clinical trial NCT02401360: A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
Official title: A Controlled Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Dental Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the efficacy of an oral hygiene regimen relative to a standard marketed toothpaste and manual toothbrush.


Eligibility criteria: Inclusion Criteria:

* give written informed consent prior to their participation;
* be 18 to 65 years of age at the time of enrollment;
* agree not to participate in any other oral/dental product studies;
* agree to delay any elective dentistry (including a dental prophylaxis);
* agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
* agree to return for the scheduled visits and follow study procedures;
* 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;
* have more than 10 bleeding sites at visits 1-3
* Consistency of bleeding site number at baseline may be considered;
* have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
* refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion Criteria:

* teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
* antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
* medical conditions that the investigator considers significant and that may compromise the evaluation of study results
* currently participating in any other clinical trial
* participated in a clinical trial for plaque/gingivitis within the previous 30 days
* pregnant or lactating
* orthodontic appliances or removable partial dentures
* soft or hard tissue tumor of the oral cavity
* advanced periodontal disease
* history of hepatitis, diabetes, or other communicable diseases
* history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
* history of significant adverse effects following the use of oral hygiene products such as toothpaste
* oral pathoses that could interfere with compliance and/or examinations or that need treatment.

Primary outcomes:
measure: Gingivitis
timeFrame: Day 0
measure: Gingivitis
timeFrame: Day 3
measure: Gingivitis
timeFrame: Day 10
measure: Gingivitis
timeFrame: Day 24
Secondary outcomes:
measure: Plaque Examination
timeFrame: Day 0
measure: Plaque Examination
timeFrame: Day 3
measure: Plaque Examination
timeFrame: Day 10
measure: Plaque Examination
timeFrame: Day 24
Other outcomes:
Locations:
Study officials:
affiliation: Procter and Gamble
name: Tao He, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: