The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

Phase 2

Completed

• Conditions: Dental Plaque and Gingivitis
• Interventions: Drug: Control toothpaste; Drug: Experimental toothpaste; Drug: Active Comparator

• Registration Number: NCT02243046
• Lead Sponsor: Colgate Palmolive

Brief Summary

This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-17
• Study Start: 2014-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Results First Submitted: 2016-01-28
• Results First Submitted QC: 2016-03-30
• Results First Posted: 2016-05-04
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control toothpaste	Control toothpaste	1450 ppm Fluoride toothpaste
Experimental toothpaste	Experimental toothpaste	1450 ppm sodium fluoride toothpaste with a zinc base
Active comparator	Active Comparator	1450 ppm sodium fluoride/triclosan toothpaste

Primary Outcome Measures

Name	Time	Method
Gingivitis Scores	6 months (from Baseline)	Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Dental Plaque Scores	6 months (from Baseline)	Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

Trial Locations

Locations (1)

Spa Dental; 🇩🇴 Santo Domingo, Dominican Republic