Psychological Impact of Tooth Loss

Partial Edentulism Clinical Trial

— Edentpsy  

Official title:

Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536468
• Other study ID #: NI17037J
• Status: Recruiting
• Start date: January 25, 2019
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Adeline Braud
• Phone: 01 40 19 39 87
• Email: adeline.braud[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous
• Partial Edentulism
• Tooth Loss

Locations

Country	Name	City	State
France	Pôle odontologie Hôpital Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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)