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Completed

NCT Number: NCT03413475

Oral Quality of Life

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital University of Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

quality of life

Behavioral

Primary outcomes

  1. Geriatric Oral Health Assessment Index (GOHAI) questionnaire

    Time frame: Day - 30

    GOHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) before the treatment when the patient is still partially dentate (Day -30).

  2. Geriatric Oral Health Assessment Index (GOHAI) questionnaire

    Time frame: Day 0

    GOHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) in the control sessions after delivery of immediate prostheses (day 0)

  3. Geriatric Oral Health Assessment Index (GOHAI) questionnaire

    Time frame: month 1

    OHAI questionnaire (Geriatric Oral Health Assessment Index) (12 questions) in the control sessions during the healing phase for patients not rehabilitated at 1 month,

  4. Geriatric Oral Health Assessment Index (GOHAI) questionnaire

    Time frame: Month 3

    after carrying out the usage prostheses during the inspection visits at 3 months (with a patient carrying his prostheses for at least 1 month).

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2018
Registry last updated
Sep 14, 2021

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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