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OpenTrials
Completed

NCT Number: NCT01906242

Hygiene Protocol of Complete Dentures

Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.

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Key information

Conditions

Denture Hygiene Protocol

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complete denture wearer
  • healthy
  • ability to comply with the experimental protocol

Exclusion criteria

  • Candidiasis (thrush)
  • use of antifungals, antibiotics or mouthwashes in the prior 3 months
  • limited motor activity
  • unhealthy

Treatment and study plan

Water

Other

Other names: placebo

sodium hypochlorite

Other

Sodium bicarbonate

Other

Chlorhexidine

Other

Primary outcomes

  1. Amount of biofilm formed on the denture

    Time frame: 14 days

    Biofilm will be measured on the denture using photographs and microbial counts (baseline and after 14 days of use of one of the four hygiene protocols) after using one of the tested denture hygiene protocols. The four tested protocols (NaOCl, chlorhexidine, sodium bicarbonate, water) will be compared to see which one leads to a better hygiene of the denture.

Secondary outcomes

  1. Odor

    Time frame: 14 days

    Patients will be asked about the odor of the solution used to soak dentures through a questionnaire

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Hygiene Protocols for Cleaning Complete Dentures

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.