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

Phase 2

Active, not recruiting

• Conditions: Plaque, Dental; Gingivitis

• Registration Number: NCT06565897
• Lead Sponsor: Colgate Palmolive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Inclusion Criteria:<br><br> - Signed Informed Consent Form.<br><br> - Male and female subjects aged 18-70 years, inclusive.<br><br> - Availability for the six-week duration of the clinical research study.<br><br> - Good general health based on the opinion of the study investigator<br><br> - Minimum of 20 permanent natural teeth (excluding third molars).<br><br> - Initial gingivitis index of at least 1.0 as determined by the use of the Loe and<br> Silness Gingival Index.<br><br> - Initial mean plaque index of at least 0.6 as determined by Navy Plaque index.<br><br>Exclusion Criteria:<br><br> - Presence of orthodontic appliances.<br><br> - Presence of partial removable dentures.<br><br> - Tumor(s) of the soft or hard tissues of the oral cavity.<br><br> - Moderate and/or advanced periodontal disease, rampant caries, or any condition that<br> the dental examiner considers exclusionary from the study.<br><br> - Five or more carious lesions requiring immediate restorative treatment.<br><br> - Antibiotic use any time during the one-month period prior to entry into the study.<br><br> - Participation in any other clinical study or test panel within the one month prior<br> to entry into the study.<br><br> - Dental prophylaxis during the past two weeks prior to baseline examinations.<br><br> - History of allergies to oral care/personal care consumer products or their<br> ingredients.<br><br> - On any prescription medicines that might interfere with the study outcome.<br><br> - An existing medical condition that prohibits eating and/or drinking for periods up<br> to 4 hours.<br><br> - History of alcohol and/or drug abuse.<br><br> - Self-reported pregnancy and/or lactating subjects.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque assessment;Gingivitis Assessment