Clinical trial NCT06565897: Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.
Official title: Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Established Plaque and Gingivitis: a 6-week Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Plaque, Dental
Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1, 3, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form.
* Male and female subjects aged 18-70 years, inclusive.
* Availability for the six-week duration of the clinical research study.
* Good general health based on the opinion of the study investigator
* Minimum of 20 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 mean plaque index of at least 0.6 as determined by Navy Plaque index.

Exclusion Criteria:

* Presence of orthodontic appliances.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* 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 and/or drinking for periods up to 4 hours.
* History of alcohol and/or drug abuse.
* Self-reported pregnancy and/or lactating subjects.

Primary outcomes:
measure: Plaque assessment
timeFrame: Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks
measure: Gingivitis Assessment
timeFrame: Initial reading, 1-week, 3-weeks, and 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Consumer Research Consulting, LLC
state: Florida
Study officials:
affiliation: Consumer Research Consulting, LLC.
name: John Gallob, DMD
role: PRINCIPAL_INVESTIGATOR
References: