Oral Quality of Life

Odontalgia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413475
• Other study ID #: RC16_0260
• Status: Completed
• Start date: January 4, 2017
• Est. completion date: May 14, 2020

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Odontalgia
• Toothache

Intervention

Behavioral:
• quality of life

Locations

Country	Name	City	State
France	Hospital University of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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