Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psychological Impact of Tooth Loss (Edentpsy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03536468
Recruitment Status : Not yet recruiting
First Posted : May 24, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

Condition or disease
Edentulous Mouth Partial Edentulism

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Gender [ Time Frame: at date of inclusion (up to 24h) ]
    Respondents complete a questionnaire identifying their gender (man or woman)

  3. Age [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents complete a questionnaire identifying their age (in years)

  4. 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)

  5. Income [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents completed a questionnaire identifying their income level each month (in euros)

  6. General health [ Time Frame: at date of inclusion (Up to 24h) ]
    Respondents complete a questionnaire indentifying their general heath and the existence of disease

  7. Dental status [ Time Frame: at date of inclusion (Up to 24h) ]
    Dental Examination is done by a dental practioner



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536468


Contacts
Layout table for location contacts
Contact: Adeline Braud 01 40 19 39 87 adeline.braud@aphp.fr
Contact: Yves Boucher 01 44 27 81 23 yves.boucher@univ-paris-diderot.fr

Locations
Layout table for location information
France
Pôle odontologie Hôpital Rothschild Not yet recruiting
Paris, France, 75002
Contact: Adeline Braud, Dr         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Study Director: Adeline Braud APHP

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03536468     History of Changes
Other Study ID Numbers: NI17037J
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tooth loss, edentulousness, psychology, oral health-related

Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Loss
Mouth, Edentulous
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases