- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879275
Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery (IBDOS)
March 13, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery: a Prospective Study
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery by using 3 validated questionnaires
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alessandro Moro, MD
- Phone Number: +390630155701
- Email: alessandro.moro@policlinicogemelli.it
Study Locations
-
-
RM
-
Rome, RM, Italy, 00168
- Fondazione Policlinico Gemelli IRCSS
-
Contact:
- Erika Mastrecchia
- Phone Number: 0630151
- Email: erika.mastrecchia@policlinicogemelli.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
candidates to orthognathic surgery
Description
Inclusion Criteria:
- Patients who are candidates for orthognathic surgery
- Age: 18 to 50 years;
- Informed consent
Exclusion Criteria:
- - Patients diagnosed with another psychiatric pathology
- Patients affected by syndromes involving the cervical-facial district
- Patients affected by clefts
- Patients affected by OSAS and candidates for orthognathic surgery for this indication
- Patients affected by connective tissue disorders (e.g. Ehler-Danlos, scleroderma, etc.)
- Patients candidates for orthognathic surgery due to facial trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary outcomes
Time Frame: 2 years
|
- Prevalence of body image disturbance (BDD) among patients undergoing orthognathic surgery.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alessandro Moro, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2025
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Study Registration Dates
First Submitted
January 21, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 13, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Tooth Diseases
- Behavioral Symptoms
- Jaw Abnormalities
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Mandibular Diseases
- Stomatognathic System Abnormalities
- Congenital Abnormalities
- Somatoform Disorders
- Malocclusion
- Problem Behavior
- Mental Disorders
- Prognathism
- Malocclusion, Angle Class III
- Body Dysmorphic Disorders
Other Study ID Numbers
- 7033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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