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Experimental Denture Pastes

Primary Purpose

Dental Plaque, Denture Stomatitis, Oral Candidiasis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Dentifrice

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Chloramine T, Complete Denture, Dental Plaque Index, Dentifrice, Denture Bases, Denture Cleansers, Edentulous Mouth, Fluorosurfactant, Oral Health, Toothpaste

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ribeirão Preto Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

0.01% fluorosurfactant

1.0% chloramine T

0.2% chloramine T

Proprietary dentifrice.

Arm Description

An experimental formula for denture hygiene containing 0.01% fluorosurfactant.

An experimental formula for denture hygiene containing 1.0% chloramine T.

An experimental formula for denture hygiene containing 0.2% chloramine T.

A proprietary denture-specific dentifrice.

Outcomes

Primary Outcome Measures

Denture plaque coverage area (%)

Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Secondary Outcome Measures

Full Information

NCT ID

NCT01237795

First Posted

November 9, 2010

Last Updated

July 24, 2014

Sponsor

Raphael Freitas de Souza

1. Study Identification

Unique Protocol Identification Number

NCT01237795

Brief Title

Experimental Denture Pastes

Official Title

A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Raphael Freitas de Souza

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Plaque, Denture Stomatitis, Oral Candidiasis, Oral Hygiene

Keywords

Chloramine T, Complete Denture, Dental Plaque Index, Dentifrice, Denture Bases, Denture Cleansers, Edentulous Mouth, Fluorosurfactant, Oral Health, Toothpaste

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.01% fluorosurfactant

Arm Type

Experimental

Arm Description

An experimental formula for denture hygiene containing 0.01% fluorosurfactant.

Arm Title

1.0% chloramine T

Arm Type

Experimental

Arm Description

An experimental formula for denture hygiene containing 1.0% chloramine T.

Arm Title

0.2% chloramine T

Arm Type

Experimental

Arm Description

An experimental formula for denture hygiene containing 0.2% chloramine T.

Arm Title

Proprietary dentifrice.

Arm Type

Active Comparator

Arm Description

A proprietary denture-specific dentifrice.

Intervention Type

Other

Intervention Name(s)

Dentifrice

Other Intervention Name(s)

Denture-specific paste, Toothpaste

Intervention Description

Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.

Primary Outcome Measure Information:

Title

Denture plaque coverage area (%)

Description

Relation between stained area and total surface area on the internal surface of maxillary complete dentures.

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helena FO Paranhos, DDS, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ribeirão Preto Dental School

City

Ribeirão Preto

State/Province

São Paulo

ZIP/Postal Code

14040-904

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://www.forp.usp.br

Description

Institutional page of the Ribeirão Preto Dental School (research site)

URL

http://lattes.cnpq.br/6275169074451249

Description

Principal Investigator´s CV

Learn more about this trial

Experimental Denture Pastes

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