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NCT01237795 Clinical Trial

Experimental Denture Pastes

Dental Plaque Clinical Trial

Official title:
A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01237795
Other study ID # FORP-PT-003
Secondary ID 2008.1.33.58.7
Status Completed
Phase N/A
First received November 9, 2010
Last updated July 24, 2014
Start date February 2008
Est. completion date December 2009

Study information
Verified date July 2014
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial aims to evaluate the efficacy of three experimental dentifrices to remove denture biofilm. Complete denture wearers will be instructed to brush their dentures with a specific toothbrush and four compositions: (1) A proprietary denture-specific paste (active comparator); (2) 0.2% chloramine T; (3) 1.0% chloramine T; (4) 0.01% fluorosurfactant. Each treatment will be used for periods of 7 days, and participants will be randomized to use them according to one of four sequences.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 2009
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Completely edentulous

- Good general health

- Patients requesting new complete dentures (volunteers will receive the interventions before new complete dentures)

- Regular wearing of the same maxillary and mandibular complete dentures for 3 to 10 years

- Both denture bases and artificial teeth should be composed by acrylic resin

Exclusion Criteria:

- Unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures)

- Absence of deposits of biofilm at baseline

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Dentifrice
Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.

Locations
Country Name City State
Brazil Ribeirão Preto Dental School Ribeirão Preto São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Raphael Freitas de Souza

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Denture plaque coverage area (%) Relation between stained area and total surface area on the internal surface of maxillary complete dentures. 7 days No
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