Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

Phase 2

Active, not recruiting

• Conditions: Gingivitis; Plaque, Dental
• Interventions: Drug: Control regimen; Drug: Test regimen

• Registration Number: NCT06565897
• Lead Sponsor: Colgate Palmolive

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-26
• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control regimen	Control regimen	Brush with full ribbon toothpaste, 2x day / 2mins with paste \& toothbrush provided
Test regimen	Test regimen	Brush with full ribbon toothpaste, 2x day / 2mins with paste \& toothbrush provided

Primary Outcome Measures

Name	Time	Method
Plaque assessment	Initial reading, reading taken immediately following first brushing, 1-week, 3-weeks, and 6-weeks	The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. Refinement of the Navy plaque index to increase plaque scoring efficiency in gum line and interproximal tooth areas.
Gingivitis Assessment	Initial reading, 1-week, 3-weeks, and 6-weeks	A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror.

Trial Locations

Locations (1)

Consumer Research Consulting, LLC; 🇺🇸 Melbourne, Florida, United States