Partial Edentulism Clinical Trial
— EdentpsyOfficial title:
Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
NCT number | NCT03536468 |
Other study ID # | NI17037J |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 25, 2019 |
Est. completion date | December 2019 |
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).
Status | Recruiting |
Enrollment | 145 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Pôle odontologie Hôpital Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hospital anxiety and depression (HAD) score | 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 | Change in General oral health assessment index (GOHAI) | 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) | |
Secondary | Gender | Respondents complete a questionnaire identifying their gender (man or woman) | at date of inclusion (up to 24h) | |
Secondary | Age | Respondents complete a questionnaire identifying their age (in years) | at date of inclusion (Up to 24h) | |
Secondary | Educational level | 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) | |
Secondary | Income | Respondents completed a questionnaire identifying their income level each month (in euros) | at date of inclusion (Up to 24h) | |
Secondary | General health | Respondents complete a questionnaire indentifying their general heath and the existence of disease | at date of inclusion (Up to 24h) | |
Secondary | Dental status | Dental Examination is done by a dental practioner | at date of inclusion (Up to 24h) |
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