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.

Colgate-Palmolive

Status and phase: Completed; Phase 3; Phase 2

Conditions: Calculus, Dental

Treatments: Drug: 0.76% sodium monofluorophosphate; Drug: 0.454% stannous fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223060

CRO-2017-04-TAR-SNDZ-YPZ

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Test 1 toothpaste

Experimental group

Treatment:

Drug: 0.454% stannous fluoride

Test 2 toothpaste

Active Comparator group

Treatment:

Drug: 0.76% sodium monofluorophosphate