- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03536468
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
Conditions
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
-
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Paris, France, 75002
- Recruiting
- Pôle odontologie Hôpital Rothschild
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Contact:
- Adeline Braud, Dr
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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 |
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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
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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)
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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.
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1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
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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)
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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.
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1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
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Gender
Time Frame: at date of inclusion (up to 24h)
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Respondents complete a questionnaire identifying their gender (man or woman)
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at date of inclusion (up to 24h)
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Age
Time Frame: at date of inclusion (Up to 24h)
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Respondents complete a questionnaire identifying their age (in years)
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at date of inclusion (Up to 24h)
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Educational level
Time Frame: at date of inclusion (Up to 24h)
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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)
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at date of inclusion (Up to 24h)
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Income
Time Frame: at date of inclusion (Up to 24h)
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Respondents completed a questionnaire identifying their income level each month (in euros)
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at date of inclusion (Up to 24h)
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General health
Time Frame: at date of inclusion (Up to 24h)
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Respondents complete a questionnaire indentifying their general heath and the existence of disease
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at date of inclusion (Up to 24h)
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Dental status
Time Frame: at date of inclusion (Up to 24h)
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Dental Examination is done by a dental practioner
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at date of inclusion (Up to 24h)
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- NI17037J
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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