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.

A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the 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.

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.

Study Overview

• Status: Completed
• Conditions: Calculus, Dental
• Intervention / Treatment: Drug: 0.454% stannous fluoride; Drug: 0.76% sodium monofluorophosphate

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10250
      • M U International Oral Science Research, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 toothpaste	Drug: 0.454% stannous fluoride; brushed twice daily, morning and evening for 2 minutes eact time
Active Comparator: Test 2 toothpaste	Drug: 0.76% sodium monofluorophosphate; brushed twice daily, morning and evening for 2 minutes eact time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supragingival calculus formation via Volpe-Manhold Calculus Index	index for comparing the amount of dental calculus	baseline and 12 week measurement

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Dutmanee Seriwatanachai, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Tooth Diseases; Dental Deposits; Pathological Conditions, Signs and Symptoms; Dental Calculus; Cariostatic Agents; Inorganic Chemicals; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Tin Compounds; Tin Fluorides; fluorophosphate
• Other Study ID Numbers: CRO-2017-04-TAR-SNDZ-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes