Quality of Life After Denture Relining (OHRQoL)

Fundação de Amparo à Pesquisa do Estado de São Paulo

Status: Completed

Conditions: Quality of Life

Treatments: Other: Denture liner Mucopren Soft; Group 1; Other: Denture liner Kooliner; Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01928706

24021985

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Denture liner Mucopren Soft; Group 1

Experimental group

Description:

The existing mandibular dentures were relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22).

Treatment:

Other: Denture liner Mucopren Soft; Group 1

Denture liner Kooliner; Group 2

Active Comparator group

Description:

The existing mandibular dentures were relined with a a hard acrylic resin based denture liner (Kooliner; Group 2 n=22).

Treatment:

Other: Denture liner Kooliner; Group 2