Clinical trial NCT01928706: Quality of Life After Denture Relining
Official title: Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: edentulism
denture liner
prosthodontics
OHIP EDENT
Lead sponsor: Fundação de Amparo à Pesquisa do Estado de São Paulo
Sponsor class: OTHER_GOV
First posted: 2013-08-27
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22) or a hard acrylic resin based denture liner (Kooliner; Group 2; control n=22) with chairside procedures. The OHIP EDENT (Oral Health Impact profile) questionnaire was given to patients prior to reline procedures (baseline-T0) and 90 days (T90) post relining. Three possible answers and scores were proposed for each question: never (0), sometimes (1) and almost always (2). Results were analyzed by means of the generalized linear model (p≤0.05) considering two factors: time (T0 and T90) and group (hard and soft denture liners).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Oral health related quality of life at 90 days after denture relining
timeFrame: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post denture relining.
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Ribeirao Preto Dental School University of Sao Paulo
state: Sao Paulo
Study officials:
affiliation: Ribeirao Preto Dental School University of Sao Paulo
name: C H Lovato, pHD
role: PRINCIPAL_INVESTIGATOR
References: