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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07223060

Enrollment

100

Registered

2025-10-31

Start date

2017-05-17

Completion date

2017-10-06

Last updated

2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculus, Dental

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.

Interventions

DRUG0.454% stannous fluoride

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

DRUG0.76% sodium monofluorophosphate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026