Quality of Life After Denture Relining
OHRQoL
Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.
1 other identifier
interventional
44
1 country
1
Brief Summary
Purpose: the aim of the present study was to analyze the impact of mandibular denture relining with soft or hard denture liners in the oral health related quality of life (OHRQoL) of edentulous patients. The null hypothesis was that there would be no difference in OHRQoL findings after mandibular denture relining between patient groups treated with hard or soft denture liners.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Mar 2009
Longer than P75 for not_applicable quality-of-life
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
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedAugust 27, 2013
August 1, 2013
2.9 years
August 6, 2013
August 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Oral health related quality of life at 90 days after denture relining
The Oral Health Related Quality of Life (OHRQoL) was assessed through the application of the questionnaire OHIP EDENT at baseline and 90 days post denture relining. Four domains developed for the Brazilian OHIP-EDENT9 were used: (D1) 'masticatory-related complaints, (D2) 'psychological discomfort and disability', (D3) 'social disability' and (D4) 'oral pain and discomfort'. The questionnaires were carried out via interviews by one individual examiner , who was blinded for the denture liner. The interviews lasted approximately ten minutes.Three possible answers to questions one to nineteen with their scores in parenthesis were given as options: never (0), sometimes (1) or almost always (2).
The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.
Study Arms (2)
Denture liner Mucopren Soft; Group 1
EXPERIMENTALThe existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22).
Denture liner Kooliner; Group 2
ACTIVE COMPARATORThe existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22).
Interventions
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
Complete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.
Eligibility Criteria
You may qualify if:
- Edentulous in both jaws
- Complete denture wearers
- Clinically acceptable occlusal relationships
- Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.
You may not qualify if:
- Residual vertical bone height of 10 mm or less
- No attached mucosa in any region of mandible (type E)
- Dentures with deteriorated intaglio surfaces
- Dentures with large pre-existing fractures
- Dentures with severely altered occlusal vertical dimension
- Extremely worn artificial teeth
- Dentures with unsatisfactory occlusions
- Neurological diseases
- Lack of motor coordination
- Difficulty of understanding instructions and the conditions of the study
- Patients with residual roots, cysts or bone spicules
- Patients with allergies to methyl methacrylate or silicone
- Knife-edge mandibular ridges.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ribeirao Preto Dental School University of Sao Paulo
Ribeirão Preto, São Paulo, 14.040-904, Brazil
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
C H Lovato, pHD
Ribeirao Preto Dental School University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dds, MsC, PhD
Study Record Dates
First Submitted
August 6, 2013
First Posted
August 27, 2013
Study Start
March 1, 2009
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
August 27, 2013
Record last verified: 2013-08