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OpenTrials
Completed

NCT Number: NCT07223060

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.

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.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

M U International Oral Science Research, Ltd.

Bangkok, 10250, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.454% stannous fluoride

Drug

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

0.76% sodium monofluorophosphate

Drug

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

Primary outcomes

  1. Supragingival calculus formation via Volpe-Manhold Calculus Index

    Time frame: baseline and 12 week measurement

    index for comparing the amount of dental calculus

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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