Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2009-03-31
2012-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Denture liner Mucopren Soft; Group 1
The existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22).
Denture liner Mucopren Soft; Group 1
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
Denture liner Kooliner; Group 2
The existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22).
Denture liner Kooliner; Group 2
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.
Interventions
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Denture liner Mucopren Soft; Group 1
Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
Denture liner Kooliner; Group 2
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complete denture wearers
* Clinically acceptable occlusal relationships
* Healthy mucosa, i.e. with no signs of inflammation, traumatic lesions, candidiasis or hyperplasia.
Exclusion Criteria
* 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.
40 Years
80 Years
ALL
Yes
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Responsible Party
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Marina Xavier Pisani
Dds, MsC, PhD
Principal Investigators
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C H Lovato, pHD
Role: PRINCIPAL_INVESTIGATOR
Ribeirao Preto Dental School University of Sao Paulo
Locations
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Ribeirao Preto Dental School University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil
Countries
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Other Identifiers
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24021985
Identifier Type: -
Identifier Source: org_study_id