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

Phase 2

Completed

• Conditions: Gingivitis; Plaque
• Interventions: Drug: Colgate Cavity Protection; Drug: Meridol

• Registration Number: NCT06563518
• Lead Sponsor: Colgate Palmolive

Brief Summary

The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-10
• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Subjects, ages 18-70, inclusive.
• Availability for the six-month duration of the clinical research study.
• Good general health.
• Minimum of 20 uncrowned 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 plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
• Signed Informed Consent Form

Exclusion Criteria

• Presence of orthodontic bands.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
• 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 or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Pregnant or lactating subjects.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Colgate Cavity Protection	Toothpaste
Group 1	Meridol	Toothpaste

Primary Outcome Measures

Name	Time	Method
Plaque Assessment	baseline, 3 months and 6 months	A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror
Gingivitis Assessment	baseline, 3 months and 6 months	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)

Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand