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Experimental Denture Pastes

A Randomized Trial of Experimental Dentifrices for Cleaning Dentures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01237795
Enrollment
36
Registered
2010-11-10
Start date
2008-02-29
Completion date
2009-12-31
Last updated
2014-07-28

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

Conditions

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

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.

Interventions

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

Sponsors

Raphael Freitas de Souza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Denture plaque coverage area (%)7 daysRelation between stained area and total surface area on the internal surface of maxillary complete dentures.

Countries

Brazil

Outcome results

None listed

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