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

NCT03687047 | Completed

• 1 other identifier: Complete denture and OHRQoL
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

DENTADURES; EDENTULOUS; MASTIGATORY PERFORMANCE

Outcome Measures

Primary Outcomes (1)

• Evaluation of oral heath related to quality of life from edentulous patient after use new complete denture

  After the installation of the new prothesis (complete denture) a follow-up (one week, three, six, nine, twelve months) will be performed. The Oral Health Impact Profile (OHIP-Edent) instrument will be applied (in form of interview) to evaluate the impact of new prothesis (complete denture) on OHRQoL.

  12 MESES

Study Arms (1)

New complete dentures

EXPERIMENTAL

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.

Device: New complete dentures

Interventions

New complete dentures 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.

New complete dentures

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Location

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 27, 2018
• Study Start: March 25, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

BR (1)