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 — Phase 2 / Phase 3, Completed, 100 participants, Colgate Palmolive

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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.

RegistryNCT07223060
StatusCompleted
PhasePhase 2 / Phase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment100 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsCalculus, Dental
Interventions0.454% stannous fluoride, 0.76% sodium monofluorophosphate (Drug)
Datesstart 2017-05-17, primary completion 2017-10-06, completion 2017-10-06, first posted 2025-10-31, last updated 2025-12-11
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Calculus, Dental All trials of 0.454% stannous fluoride All trials of 0.76% sodium monofluorophosphate

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Test 1 toothpasteExperimentalDrug: 0.454% stannous fluoride
Test 2 toothpasteActive comparatorDrug: 0.76% sodium monofluorophosphate
  • 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

+Outcome measures

Primary outcomes

  • Supragingival calculus formation via Volpe-Manhold Calculus Index [baseline and 12 week measurement]: index for comparing the amount of dental calculus

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
M U International Oral Science Research, Ltd.Bangkok, BangkokThailand

+Investigators