Status:
COMPLETED
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.
Lead Sponsor:
Colgate Palmolive
Conditions:
Calculus, Dental
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 contr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07223060
Start Date
May 17 2017
End Date
October 6 2017
Last Update
December 11 2025
Active Locations (1)
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1
M U International Oral Science Research, Ltd.
Bangkok, Bangkok, Thailand, 10250