Edentulous MouthEdentpsyNCT03536468
Psychological Impact of Tooth Loss
An observational study of Edentulous Mouth and Partial Edentulism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edentulous Mouth, Partial Edentulism
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2019to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière
Who may be able to join
- willing to participate to the study
- dental status identified
Who cannot join
- uncooperative ou patient not able to complete the questionary
- adult patients under protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle odontologie Hôpital Rothschild
Paris, 75002
Adeline Braud, Dr
About this study
Official title: Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
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).
Read the 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.
- Conditions
- Edentulous Mouth, Partial Edentulism
- Keywords
- Tooth loss, edentulousness, psychology, oral health-related
- Medical subject headings
- Mouth, Edentulous, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
Secondary outcomes (7)
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.
Measured: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
Gender
Respondents complete a questionnaire identifying their gender (man or woman)
Measured: at date of inclusion (up to 24h)
Age
Respondents complete a questionnaire identifying their age (in years)
Measured: at date of inclusion (Up to 24h)
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)
Measured: at date of inclusion (Up to 24h)
Income
Respondents completed a questionnaire identifying their income level each month (in euros)
Measured: at date of inclusion (Up to 24h)
General health
Respondents complete a questionnaire indentifying their general heath and the existence of disease
Measured: at date of inclusion (Up to 24h)
Dental status
Dental Examination is done by a dental practioner
Measured: at date of inclusion (Up to 24h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start25 Jan 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline Braud, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536468
- Sponsor's protocol ID
- NI17037J
- Acronym
- Edentpsy
- Status last verified
- Nov 2018
- First submitted
- 13 Apr 2018
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
- ClinicalTrials.gov ID
- NCT03536468
- Acronym / sponsor ID
- Edentpsy / NI17037J
- Conditions
- Edentulous Mouth, Partial Edentulism
- Keywords
- Tooth loss, edentulousness, psychology, oral health-related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière
Key inclusion criteria (2 listed)
- willing to participate to the study
- dental status identified
Key exclusion criteria (2 listed)
- uncooperative ou patient not able to complete the questionary
- adult patients under protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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)
Gender
Time frame: at date of inclusion (up to 24h)
Age
Time frame: at date of inclusion (Up to 24h)
Educational level
Time frame: at date of inclusion (Up to 24h)
Income
Time frame: at date of inclusion (Up to 24h)
General health
Time frame: at date of inclusion (Up to 24h)
Dental status
Time frame: at date of inclusion (Up to 24h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Braud study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Mouth and Partial Edentulism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeline Braud (01 40 19 39 87, adeline.braud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.