Determining the effects of orthogenetic surgery on mental health, quality of life and perfectionism of candidate patients
Design
This clinical trial consists of a group of 32 orthodontic surgery candidates in a non-randomly accessible manner performed on 32 orthodontic patients.
Settings and conduct
Candidate patients for maxillofacial surgery who refer to the clinic and surgical departments affiliated to Isfahan University of Medical Sciences and the office of the maxillofacial surgeon are evaluated in terms of entry and non-entry criteria. Eligible candidates will receive written consent. Orthognathic surgery is performed by a maxillofacial surgeon (executor of plan) at Al-Zahra Hospital in Isfahan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 50 years old; Persian speaker; minimum literacy to read and write and informed consent to participate in the study. Non-entry criteria: cleft lip and palate; severe congenital abnormalities; severe trauma injuries and major Psychiatric and neurological disorders.
Intervention groups
The intervention group are candidate patients for orthognathic surgery. The intervention is orthognathic surgery performed by a maxillofacial surgeon.
Main outcome variables
Quality of life scores; Depression scores; Anxiety; Stress; Perfectionism score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110815007339N4
Registration date:2022-01-22, 1400/11/02
Registration timing:retrospective
Last update:2022-01-22, 1400/11/02
Update count:0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Amrollah Ebrahimi
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8818
Email address
a_ebrahimi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
2020-05-04, 1399/02/15
Actual recruitment end date
2020-09-15, 1399/06/25
Trial completion date
2021-02-13, 1399/11/25
Scientific title
Effects of orthognathic surgery on perfectionism, mental health and quality of life
Public title
Orthognathic surgery and mental health and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years old
Persian speaker
Minimum literacy to read and write
Consent to participate in the study
Exclusion criteria:
Cleft lip and cleft palate
Abnormalities due to congenital disorder which necessitates surgeries
Impairments due to severe trauma
Major psychiatric and neurological disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Actual sample size reached:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics committee. Isfahan University of Medical Sciences
Street address
Hezarjerib street
City
Isfaha
Province
Isfehan
Postal code
81746-73461
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.MUI..RESEARCH.REC1399.455
Health conditions studied
1
Description of health condition studied
Dentofacial deformity
ICD-10 code
M26
ICD-10 code description
Dentofacial deformity
Primary outcomes
1
Description
Orthognathic Quality of Life Questionnaire
Timepoint
Before intervention (surgery) and six months after surgery
Method of measurement
Self-report questionnaire
2
Description
Depression
Timepoint
Before surgery and six months after surgery
Method of measurement
Self-report questionnaire
3
Description
Anxiety
Timepoint
Before and six months after surgery
Method of measurement
Self-report questionnaire
4
Description
Stress
Timepoint
Before and six months after surgery
Method of measurement
Self-report questionnaire
5
Description
Perfectionism
Timepoint
Before and six months after surgery
Method of measurement
Self-report questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: orthognathic surgeryAfter approving the plan in the research vice chancellor of Isfahan University of Medical Sciences and receiving the code of ethics from the ethics committee, patients who were candidates for orthognathic surgery and met the inclusion criteria were selected by referring to an oral and maxillofacial surgeon in medical centers affiliated to Isfahan University of Medical Sciences. . After gaining their trust and explaining the objectives of the research, written informed consent was obtained and questionnaires were completed. Orthognathic surgery performed according to the patient's problem and diagnosis of abnormality included mandibular, maxillary or both maxillofacial surgery performed by a maxillofacial surgeon during a session in the operating room of Al-Zahra Hospital. The type of operation was orthognathic surgery, known as jaw correction surgery or simply jaw surgery, and is designed to correct the condition of the jaw and face as well as a wide range of imbalance, asymmetry, asymmetry and facial fit to improve function and improve aesthetics. . Patients were followed up by a physician at least 6 months after surgery and a questionnaire was completed again.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial surgery ward in Al-Zahra Hospital
Full name of responsible person
Dr. Abbas Haghighat
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abbas Haghighat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 5551
Email
Haghighat@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
a_ebrahimi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 9313
Email
a_ebrahimi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The analyses of the data will be published as a scientific article.