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Completed

NCT Number: NCT03687047

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal Fluminense

Nova Friburgo, Rio de Janeiro, 28625650, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 MESES

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Sep 27, 2018
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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