Quality of Life After Denture Relining

Quality of Life Clinical Trial

— OHRQoL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928706
• Other study ID #: 24021985
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: August 21, 2013
• Start date: March 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Quality of Life

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Ribeirao Preto Dental School University of Sao Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes