Psychological Impact of Tooth Loss (Edentpsy)

November 14, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic

Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological conditions of patients pending complete tooth extraction before and shortly after tooth loss using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index (GOHAI).

Study Overview

Status

Unknown

Detailed Description

Patients will be interviewed concerning their psychological conditions (HADS) and their oral health related quality of life (GOHAI) before tooth extraction and one month after complete tooth loss.

Study Type

Observational

Enrollment (Anticipated)

145

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75002
        • Recruiting
        • Pôle odontologie Hôpital Rothschild
        • Contact:
          • Adeline Braud, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière

Description

Inclusion Criteria:

  • willing to participate to the study
  • dental status identified

Exclusion Criteria:

  • uncooperative ou patient not able to complete the questionary
  • adult patients under protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients pending complete tooth loss
Will be recruited patients pending tooth loss, ages between 18 and 65 years, whose dental conditions have previously been identified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hospital anxiety and depression (HAD) score
Time Frame: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
The HADS is a 14-item self-assessment scale designed to evaluate emotional stress induced by chronic pain in non-psychiatric populations. HAD-A assessed anxiety and HAD-D evaluated depression. Scores of greater than 10 were indicative of anxiety or depression, scores of 7 or less were indicative of no significant anxiety and depression, and scores of 8 to 10 indicated borderline anxiety or depression.
1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in General oral health assessment index (GOHAI)
Time Frame: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
The General oral health assessment index (GOHAI) is a questionnaire about the impact of oral health on quality of life. It includes 12 items evaluating three dimensions of oral health with respect to quality of life: (1) functional field (eating, speaking, and swallowing); (2) psychological field (appearance, social relationship); (3) pain or discomfort concerning gums or teeth. Each item has a score ranging from 1 to 5. The GOHAI-add score corresponds to the sum of the scores and ranges from 12 to 60 (20 for functional field, 25 for psychological field, and 15 for comfort/pain field). A score higher than 57 is high and indicates a satisfactory oral quality of life. A score from 51 to 56 is average and a score of 50 or less is low, reflecting a poor oral quality of life.
1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
Gender
Time Frame: at date of inclusion (up to 24h)
Respondents complete a questionnaire identifying their gender (man or woman)
at date of inclusion (up to 24h)
Age
Time Frame: at date of inclusion (Up to 24h)
Respondents complete a questionnaire identifying their age (in years)
at date of inclusion (Up to 24h)
Educational level
Time Frame: at date of inclusion (Up to 24h)
Respondents complete a questionnaire identifying their educational level : last degree (no degree at al, French General Certificate Secondary Education, High School Diploma, Vocational Training Certificate taken at Secondary School, university degree)
at date of inclusion (Up to 24h)
Income
Time Frame: at date of inclusion (Up to 24h)
Respondents completed a questionnaire identifying their income level each month (in euros)
at date of inclusion (Up to 24h)
General health
Time Frame: at date of inclusion (Up to 24h)
Respondents complete a questionnaire indentifying their general heath and the existence of disease
at date of inclusion (Up to 24h)
Dental status
Time Frame: at date of inclusion (Up to 24h)
Dental Examination is done by a dental practioner
at date of inclusion (Up to 24h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Adeline Braud, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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