Psychological Impact of Tooth Loss (Edentpsy)

• ClinicalTrials.gov Identifier: NCT03536468
• Recruitment Status: Unknown
• First Posted: May 24, 2018
• Last Update Posted: November 15, 2019
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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

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

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

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