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Psychological Impact of Tooth Loss (Edentpsy)

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ClinicalTrials.gov Identifier: NCT03536468
Recruitment Status : Unknown
Verified November 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : May 24, 2018
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date April 13, 2018
First Posted Date May 24, 2018
Last Update Posted Date November 15, 2019
Actual Study Start Date January 25, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2018)
  • 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.
  • Gender [ Time Frame: at date of inclusion (up to 24h) ]
    Respondents complete a questionnaire identifying their gender (man or woman)
  • Age [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents complete a questionnaire identifying their age (in years)
  • 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)
  • Income [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents completed a questionnaire identifying their income level each month (in euros)
  • General health [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents complete a questionnaire indentifying their general heath and the existence of disease
  • Dental status [ Time Frame: at date of inclusion (Up to 24h) ]
    Dental Examination is done by a dental practioner
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological Impact of Tooth Loss
Official Title Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
Brief Summary 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).
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière
Condition
  • Edentulous Mouth
  • Partial Edentulism
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 14, 2018)
145
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03536468
Other Study ID Numbers NI17037J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Study Director: Adeline Braud APHP
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2018