Slctr

Health related quality of life and satisfaction following orthognathic surgery in Omani patients

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SLCTR Registration Number

SLCTR/2024/017

Date of Registration

14 May 2024

The date of last modification

May 14, 2024

Application Summary

Scientific Title of Trial

Health related quality of life and satisfaction following orthognathic surgery in Omani patients

Public Title of Trial

Effect of orthognathic surgery on quality of life and satisfaction among patients with dentofacial deformities compared to pre-surgery state

Disease or Health Condition(s) Studied

Dentofacial Deformities and Anomalies

Scientific Acronym

QoLSOS

Public Acronym

None

Brief title

Quality of life and satisfaction following orthognathic surgery

Universal Trial Number

U1111-1303-9750

Any other number(s) assigned to the trial and issuing authority

ERC No: MOH/ANH/RC/12/2019 ODC-RG-ASAE-2023-171

Trial Details

What is the research question being addressed?

How does orthognathic surgery impact the quality of life and satisfaction levels among patients with dentofacial deformities compared to their pre-surgery state?

Type of study

Interventional

Study design

Allocation

Single arm study

Masking

Masking not used

Control

Uncontrolled

Assignment

Single

Purpose

Treatment

Study Phase

Not Applicable

Intervention(s) planned

The study will be conducted in a hospital-based setting, specifically within the Department of Oral and Maxillofacial Surgery at Oman Dental College, located in Muscat, Oman. Patients planned for orthognathic surgery will be recruited from the outpatient clinic of the Department of Oral and Maxillofacial Surgery.
Le Fort I osteotomy: Surgery performed on the upper jaw to correct alignment issues.
Bilateral sagittal split osteotomy (BSSO): Surgery on the lower jaw to address its positioning.
Genioplasty: Surgery to modify the chin, which can be part of the treatment for aesthetic or functional reasons.
Maxillary advancement or setback: Procedures to adjust the position of the upper jaw forward or backward.
Mandibular advancement or setback: Procedures to adjust the position of the lower jaw.

Inclusion criteria

Inclusion Criteria: - Individuals officially diagnosed with dentofacial deformities and deemed eligible for orthognathic surgery to correct these conditions.

Patients scheduled to undergo any type of orthognathic surgery at the Dental and Maxillofacial Surgery Department of the study site within the 12-month study period.
Patients aged 18 years or older.

-All genders.

Patients must possess the ability to self-administer the questionnaire. This includes having the literacy and comprehension skills necessary to understand and respond accurately to the modified validated Arabic version of the Orthognathic Quality of Life Questionnaire (OQLQ) and the visual analogue scales (VAS). T

Exclusion criteria

Exclusion Criteria:

Non-Arabic speakers who cannot understand or accurately complete the questionnaire due to language barriers, since the questionnaire is provided solely in Arabic.
Individuals with cognitive impairments that impede their ability to understand the consent process or to accurately fill out the questionnaires.
Patients who have already undergone orthognathic surgery, ensuring the study focuses exclusively on outcomes from first-time surgical procedures.
Patients with severe systemic diseases or health conditions that might affect the surgery's outcomes or their ability to participate fully in the study.

Primary outcome(s)

Quality of Life (QoL): Metric/Method of Measurement: Orthognathic Quality of Life Questionnaire (OQLQ), a modified validated Arabic version, consisting of 22 questions across four sections: aesthetic, social impact, oro-dental function, and facial appearance perception. The score ranges from 0 to 88, with lower scores indicating better QoL.

[
Pre-surgery (on admission day), 2 weeks post-surgery, 3 months post-surgery, and 6 months post-surgery.
]

Secondary outcome(s)

1. Psychological Status: Metric/Method of Measurement: Visual Analogue Scale (VAS) for psychological status, with scores ranging from 0 (worst) to 100 (best).	[ Pre-surgery and post-surgery (the exact post-surgery timepoints for this measure are not specified, assuming the same as QoL measurement if not otherwise noted). ]
2. Satisfaction with Surgery Outcome: Metric/Method of Measurement: Visual Analogue Scale (VAS) for satisfaction, ranging from 0 (no satisfaction) to 100 (full satisfaction).	[ At 6 months post-surgery ]

Target number/sample size

Countries of recruitment

Oman

Anticipated start date

2024-05-12

Anticipated end date

2024-08-31

Date of first enrollment

2024-05-13

Date of study completion

Recruitment status

Pending

Funding source

None

Regulatory approvals

Ethics, Research & Innovation Committee (ERIC), Oman Dental College, Muscat, Oman

State of Ethics Review Approval

Status

Approved

Date of Approval

2019-12-08

Approval number

MOH/ANH/RC/12/2019

Details of Ethics Review Committee

Name:	Abubaker Edin Qutieshat
Institutional Address:	Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
Telephone:	0096824665555
Email:	research@staff.odc.edu.om

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Abubaker Edin Qutieshat
Assistant Professor
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
6479151504

aqutieshat@dundee.ac.uk

Contact Person for Public Queries

Abubaker Edin Qutieshat
Assistant Professor
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
6479151504

aqutieshat@dundee.ac.uk

Primary study sponsor/organization

Abubaker Edin Qutieshat
Research Head
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
6479151504

research@staff.odc.edu.om

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results