NCT06879275

Brief Summary

Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
45mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
May 2025Jan 2030

First Submitted

Initial submission to the registry

January 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

March 17, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

January 21, 2025

Last Update Submit

March 13, 2025

Conditions

Orthognathic Surgical ProceduresPsychiatric DisordersPrognathism

Keywords

orthognatic surgerybody dismorphic disorderprognathismaesthetic surgery

Outcome Measures

Primary Outcomes (1)

  • primary outcomes

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

    2 years

Interventions

Questionnaire and Physical ExamDIAGNOSTIC_TEST

2 self administered questionnaire for diagnosis of dismorphophobia will be administered

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

candidates to orthognathic surgery

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCSS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Mental DisordersPrognathism

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMandibular DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Alessandro Moro, MD

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Moro, MD

CONTACT

+390630155701alessandro.moro@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

March 17, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

March 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)