Hygiene Protocol of Complete Dentures
Hygiene Protocols for Cleaning Complete Dentures
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedNovember 15, 2018
November 1, 2018
3 months
May 3, 2013
November 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of biofilm formed on the denture
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.
14 days
Secondary Outcomes (1)
Odor
14 days
Study Arms (4)
Water
PLACEBO COMPARATORPatients' dentures are treated with water (placebo) once a week for 10 min.
sodium hypochlorite
ACTIVE COMPARATORPatients' dentures are treated with a solution of sodium hypochlorite 0.5% once per week for 10 min
0.5% chlorhexidine
ACTIVE COMPARATORPatients' dentures are treated with 0.5% chlorhexidine once a week for 10 min.
0.12% sodium bicarbonate
ACTIVE COMPARATORPatients' dentures are treated with sodium bicarbonate 0.12% once a week for 10 min.
Interventions
Eligibility Criteria
You may qualify if:
- Complete denture wearer
- healthy
- ability to comply with the experimental protocol
You may not qualify if:
- Candidiasis (thrush)
- use of antifungals, antibiotics or mouthwashes in the prior 3 months
- limited motor activity
- unhealthy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry
Pelotas, Rio Grande do Sul, 96015-560, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatiana Pereira-Cenci, PhD
Federal University of Pelotas
- STUDY CHAIR
Maximiliano S Cenci, PhD
Federal University of Pelotas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 3, 2013
First Posted
July 24, 2013
Study Start
April 1, 2013
Primary Completion
July 1, 2013
Study Completion
December 1, 2013
Last Updated
November 15, 2018
Record last verified: 2018-11