CompletedNot Applicable

Oral Quality of Life

France59 participantsStarted 2017-01-04

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Day - 30

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Day 0

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: month 1

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Month 3

Trial details

NCT IDNCT03413475

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-05-14

View on ClinicalTrials.gov More Odontalgia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Day - 30

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Day 0

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: month 1

Geriatric Oral Health Assessment Index (GOHAI) questionnaire

Timeframe: Month 3