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

Quality of Life Clinical Trial

Official title:

Evaluation the Impact of the Use of New Complete Denture (Prothesis) on the OHRQoL in Total Edentulous Patients Comparing to Dentate Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687047
• Other study ID #: Complete denture and OHRQoL
• Status: Completed
• Phase: N/A
• Start date: March 25, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2022
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous
• Mouth, Edentulous
• Quality of Life

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal Fluminense	Nova Friburgo	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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