ClinicalTrials.gg
Not yet recruitingNCT06879275IBDOSUpdated Mar 17, 2025

Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery

An observational study in Orthognathic Surgical Procedures, Psychiatric Disorders and Prognathism, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Orthognathic Surgical Procedures
  • Psychiatric Disorders
  • Prognathism

Keywords

  • orthognatic surgery
  • body dismorphic disorder
  • prognathism
  • aesthetic surgery
03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 90 is below the median of 220 across 389 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

candidates to orthognathic surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are candidates for orthognathic surgery
  • Age: 18 to 50 years;

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testQuestionnaire and Physical Exam

    2 self administered questionnaire for diagnosis of dismorphophobia will be administered

06

What researchers measure

Primary outcomes

  1. primary outcomes

    - Prevalence of body image disturbance (BDD) among patients undergoing orthognathic surgery.

    Time frame: 2 years

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2025; primary completion for Jan 2030, 56 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 21, 2025
First posted
Mar 17, 2025
StartEst.
May 1, 2025
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06879275
Responsible party
Sponsor
First posted
Mar 17, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Mar 17, 2025

Study contacts

Alessandro Moro, MD
Contact
alessandro.moro@policlinicogemelli.it
+390630155701
Alessandro Moro, MD
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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