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Completed

NCT Number: NCT01928706

Quality of Life After Denture Relining

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.

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Key information

Conditions

Quality of Life

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ribeirao Preto Dental School University of Sao Paulo

Ribeirão Preto, São Paulo, 14.040-904, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Denture liner Mucopren Soft; Group 1

Other

Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)

Other names: Mucopren Soft relining

Denture liner Kooliner; Group 2

Other

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 names: Kooliner

Primary outcomes

  1. Change from Baseline in Oral health related quality of life at 90 days after denture relining

    Time frame: The oral health related quality of life was evaluated before relining (T0- baseline), and after 90 days post 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).

Sponsors and collaborators

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Other Gov

Registry information

Official study title

Oral Health Related Quality of Life of Edentulous Patients After Relining Mandibular Dentures With Soft and Hard Denture Liners.

Acronym: OHRQoL

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2013
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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