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.

NCT07223060 | Completed Phase 2 FDA Drug

• 1 other identifier: CRO-2017-04-TAR-SNDZ-YPZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Calculus, Dental

Outcome Measures

Primary Outcomes (1)

• Supragingival calculus formation via Volpe-Manhold Calculus Index

  index for comparing the amount of dental calculus

  baseline and 12 week measurement

Study Arms (2)

Test 1 toothpaste

EXPERIMENTAL

Drug: 0.454% stannous fluoride

Test 2 toothpaste

ACTIVE COMPARATOR

Drug: 0.76% sodium monofluorophosphate

Interventions

0.454% stannous fluoride DRUG

brushed twice daily, morning and evening for 2 minutes eact time

Test 1 toothpaste

0.76% sodium monofluorophosphate DRUG

brushed twice daily, morning and evening for 2 minutes eact time

Test 2 toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

M U International Oral Science Research, Ltd.

Bangkok, Bangkok, 10250, Thailand

Location

MeSH Terms

Conditions

Dental Calculus

Interventions

Tin Fluorides; fluorophosphate

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Dutmanee Seriwatanachai

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: May 17, 2017
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: December 11, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)