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Quality of Life After Denture Relining

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01928706
Acronym
OHRQoL
Enrollment
44
Registered
2013-08-27
Start date
2009-03-31
Completion date
2012-05-31
Last updated
2013-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

edentulism, denture liner, prosthodontics, OHIP EDENT

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).

Interventions

OTHERDenture 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)

OTHERDenture 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.

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Oral health related quality of life at 90 days after denture reliningThe 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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026