Impact of the Use of New Complete Denture on the Oral Health Related to Quality of Life (OHRQoL)

NCT ID: NCT03687047

Last Updated: 2022-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-25
• Study Completion Date: 2018-12-01

Brief Summary

The aim of this project was to evaluate the impact before and after (3, 6, 9, and 12 months) of oral rehabilitation with conventionalof the insertion of new complete dentures (CD) in the oral health-related quality of life (OHRQoL) in total edentulous patients compared to dentate individuals. This is a clinical trial study approved by the Research Ethics Committee (nº 31105714.7.0000.5626 ) which was conducted on 122 patients who attended the clinics of Federal Fluminense University, with the necessity of CD. The eligibility criteria were: healthy patients without disabilities; aged up to 50 years; complete upper and or lower jaw edentulism for a minimum 5 years; the presence of adequate healthy tissue to support the prosthesis; adequate cognitive ability and understanding to respond to the questions posed. It will be excluded patient with motor disabilities, cognitive impairment and people with special needs. After the installation of the CD a follow-up of one week, three, six, nine, twelve and eighteen months will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of an interview) to evaluate the impact of CD on OHRQoL. The scores of the OHIP-Edent index will be calculated using the additive method, summing the numeric response codes for each item. Shapiro-Wilk test revealed nonparametric distribution of data. Chi-square, Mann-Whitney U, and Kruskal-Wallis tests were performed for comparing groups according to sociodemographic data. Kruskal-Wallis test was per- formed for comparing groups and treatments throughout time. A significance level of 5% was adopted, and all analyses were performed on Statistical Analysis System (SAS) version 9.3 software. The responsiveness was assessed by analyzing the change of the scores on the scales and subscales. The changes was calculated by subtracting the post-treatment scores from the before-treatment scores. Positive change scores will indicate an improvement in OHRQoL, while negative scores will indicate deterioration.

Conditions

Edentulous Jaw; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New complete dentures

Steps: 1) Preliminary impressions will be done using stock trays and impression compound; 2) primary casts will be fabricated to make custom trays for definitive impressions; 3) definitive impressions will be made using zinc oxide eugenol impression paste;4) definitive impressions will be poured with type III dental stone to obtain mastercasts; 5)jaw relations will be recorded, and the casts will be mounted on the articulator; 6) the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up. After denture insertion, post-denture insertion instructions such as oral hygiene will be explained to the patients.

The Oral Health Related to Quality of Life assessment will be conducted before treatment (Baseline) and at 3, 6, 9, 12 months after treatment.

Group Type: EXPERIMENTAL

New complete dentures

Intervention Type: DEVICE

Preliminary impressions using stock trays and impression compound; primary casts fabricated to make custom trays for definitive impressions; definitive impressions using zinc oxide eugenol impression paste; definitive impressions poured with type III dental stone to obtain mastercasts; jaw relations will be recorded, and the casts will be mounted on the articulator; the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up.

Interventions

New complete dentures

Preliminary impressions using stock trays and impression compound; primary casts fabricated to make custom trays for definitive impressions; definitive impressions using zinc oxide eugenol impression paste; definitive impressions poured with type III dental stone to obtain mastercasts; jaw relations will be recorded, and the casts will be mounted on the articulator; the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• healthy patients without disabilities;
• aged up to 50 years;
• patient with complete upper and or lower jaw edentulism for a minimum 5 years;
• patient with presence of adequate healthy tissue to support the prosthesis;
• patient with adequate cognitive ability and understanding to respond to the questions posed

Exclusion Criteria

• patient with motor disabilities;
• patient with cognitive impairment
• people with special needs.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal Fluminense

OTHER

Sponsor Role: lead

Responsible Party

Livia Azeredo Alves Antunes

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

Complete denture and OHRQoL

Identifier Type: -

Identifier Source: org_study_id