Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.

Phase 2

Completed

• Conditions: Gingivitis; Plaque

• Registration Number: NCT06563518
• 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: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Inclusion Criteria:<br><br> - Subjects, ages 18-70, inclusive.<br><br> - Availability for the six-month duration of the clinical research study.<br><br> - Good general health.<br><br> - Minimum of 20 uncrowned 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 plaque index of at least 1.5 as determined by the use of the Quigley and<br> Hein Plaque Index (Turesky Modification).<br><br> - Signed Informed Consent Form<br><br>Exclusion Criteria:<br><br> - Presence of orthodontic bands.<br><br> - Presence of partial removable dentures.<br><br> - Tumor(s) of the soft or hard tissues of the oral cavity.<br><br> - Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive<br> loss of periodontal attachment or alveolar bone).<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 or drinking for periods up to 4<br> hours.<br><br> - History of alcohol or drug abuse.<br><br> - Pregnant or lactating subjects.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gingivitis Assessment;Plaque Assessment