Orthognathic Surgical ProceduresIBDOSNCT06879275
Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery
An observational study of Orthognathic Surgical Procedures and Psychiatric Disorders, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgical Procedures, Psychiatric Disorders, Prognathism
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: candidates to orthognathic surgery
Who may be able to join
- Patients who are candidates for orthognathic surgery
- Age: 18 to 50 years;
- Informed consent
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Gemelli IRCSS
Rome, RM, 00168
Erika Mastrecchia, 0630151, erika.mastrecchia@policlinicogemelli.it
About this study
Official title: 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
Read the detailed description
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery by using 3 validated questionnaires
- Being tested
- Questionnaire and Physical Exam
- Keywords
- orthognatic surgery, body dismorphic disorder, prognathism, aesthetic surgery
- Medical subject headings
- Mental Disorders, Prognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamDiagnostic test
2 self administered questionnaire for diagnosis of dismorphophobia will be administered
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcomes
- Prevalence of body image disturbance (BDD) among patients undergoing orthognathic surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Moro, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879275
- Sponsor's protocol ID
- 7033
- Acronym
- IBDOS
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT06879275
- Acronym / sponsor ID
- IBDOS / 7033
- Keywords
- orthognatic surgery, body dismorphic disorder, prognathism, aesthetic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 17 Mar 2025 (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.
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery
Detailed description
Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery by using 3 validated questionnaires
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- candidates to orthognathic surgery
Key inclusion criteria (3 listed)
- Patients who are candidates for orthognathic surgery
- Age: 18 to 50 years;
- Informed consent
Key exclusion criteria (6 listed)
- - 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical Exam2 self administered questionnaire for diagnosis of dismorphophobia will be administered | Diagnostic test | – |
Primary outcome
primary outcomes
Time frame: 2 years
- Prevalence of body image disturbance (BDD) among patients undergoing orthognathic surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Alessandro Moro, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Orthognathic Surgical Procedures and Psychiatric Disorders, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Moro, MD (+390630155701, alessandro.moro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcomes (time frame: 2 years). 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 17 Mar 2025.