Oral Quality of Life

NCT03413475 | Completed

• 1 other identifier: RC16_0260
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Odontalgia

Keywords

Edentulism; complete removable prosthesis; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

quality of life BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Hospital University of Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Toothache

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Laurent Le Guehennec, DDS, PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 29, 2018
• Study Start: January 4, 2017
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

FR (1)