Oral Quality of Life

Oral Quality of Life of Patients to be Totally Edentulous at One Arch at Least and Benefiting From the Realization of Immediate and Usual Complete Removable Prostheses.

The restorative and surgical odontological department at the Nantes University Hospital frequently hosts patients with a severely degraded oral condition who has never benefited from a removable prosthetic rehabilitation. The chosen treatment plan consists most of the time in extracting all the residual teeth at one or both arches with the immediate insertion of a complete removable prosthesis performed prior to the extractions. This prosthesis is adapted by regular relining during the osteomucosal healing and is replaced by a usage removable prosthesis on average 6 months after the extractions.

The transition from dentate state (even dilapidated) to toothless state can be a source of discomfort and impairment and lead to a decrease of life's quality for patients. The purpose of this study is to evaluate oral health of the patients at the different stages of prosthetic rehabilitation by using GOHAI (Geriatric Oral Health Assessment Index).

Study Overview

• Status: Completed
• Conditions: Odontalgia
• Intervention / Treatment: Behavioral: quality of life

Detailed Description

Patients are selected at the beginning of their prosthetic rehabilitation and selected patients give their consent for the participation at the clinical trial. The filling of the GOHAI questionnaire is performed in 3 steps:1- before treatment, 2- after teeth extractions and the delivering of immediate complete denture or without immediate prosthetic rehabilitation and 3-during inspection visits after the delivery of the definitive denture.

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Hospital University of Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients treated for prosthetic rehabilitation with the need for a total edentemant of at least one arch, and setting up a complete removable prosthesis

Description

Inclusion Criteria:

• An adult man or a woman, speaking and understanding French, benefiting from social security cover.
• Patient presenting one or more teeth to be extracted, these extractions resulting in a complete uni or bimaxillary edentulism rehabilitated or not by an immediate complete removable prosthesis.

Exclusion Criteria:

• Patients under the age of majority, patients under protection, protected persons, patients refusing to participate in the study, patients whose follow-up can't be performed, patients who don't speak French and patients who don't benefit from social coverage.
• Patients rehabilitated by immediate partial removable prosthesis (persistence of teeth on the rehabilitated arch).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geriatric Oral Health Assessment Index (GOHAI) questionnaire	GOHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) before the treatment when the patient is still partially dentate (Day -30).	Day - 30
Geriatric Oral Health Assessment Index (GOHAI) questionnaire	GOHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) in the control sessions after delivery of immediate prostheses (day 0)	Day 0
Geriatric Oral Health Assessment Index (GOHAI) questionnaire	OHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) in the control sessions during the healing phase for patients not rehabilitated at 1 month,	month 1
Geriatric Oral Health Assessment Index (GOHAI) questionnaire	after carrying out the usage prostheses during the inspection visits at 3 months (with a patient carrying his prostheses for at least 1 month).	Month 3

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Laurent Le Guehennec, DDS, PhD, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2017
• Primary Completion (ACTUAL): May 14, 2020
• Study Completion (ACTUAL): May 14, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; Edentulism; complete removable prosthesis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache
• Other Study ID Numbers: RC16_0260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No