Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.

Not Applicable

Completed

• Conditions: Calculus, Dental
• Interventions: Drug: 0.454% stannous fluoride; Drug: 0.76% sodium monofluorophosphate

• Registration Number: NCT07223060
• Lead Sponsor: Colgate Palmolive

Brief Summary

To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-17
• Primary Completion: 2017-08-06
• Study Completion: 2017-08-06
• Status Verified: 2025-10
• Study First Submitted: 2025-10-29
• Study First Submitted QC: 2025-10-29
• Last Update Submitted: 2025-10-29
• Study First Posted: 2025-10-31
• Last Update Posted: 2025-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects were required to sign an Informed Consent form
• Subjects had to be in general good health
• Male and female adults between the ages of 18-70 (inclusive)
• Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
• Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
• Subjects had to be able to participate for the full duration (20 weeks) of the study

Exclusion Criteria

• Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer
• Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
• Moderate or advanced periodontal disease
• Five or more carious lesions requiring immediate care
• Use of antibiotics or steroids any time during one month prior to entry into the study
• Participation in any other clinical study or panel test
• Pregnant or breast feeding women
• History of allergies to dentifrice and personal care ingredients
• Allergies to dentifrice products
• Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test 1 toothpaste	0.454% stannous fluoride	-
Test 2 toothpaste	0.76% sodium monofluorophosphate	-

Primary Outcome Measures

Name	Time	Method
Supragingival calculus formation via Volpe-Manhold Calculus Index	baseline and 12 week measurement	index for comparing the amount of dental calculus

Trial Locations

Locations (1)

M U International Oral Science Research, Ltd.; 🇹🇭 Bangkok, Bangkok, Thailand