Home » Trials » SLCTR/2025/001
Comparative Analysis of Pre- and Postoperative Dexamethasone Administration in Lower Third Molar Surgery: A Randomized Controlled Trial
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SLCTR Registration Number
SLCTR/2025/001
Date of Registration
The date of last modification
Feb 17, 2025
View original TRDS
Scientific Title of Trial
Comparative Analysis of Pre- and Postoperative Dexamethasone Administration in Lower Third Molar Surgery: A Randomized Controlled Trial
Public Title of Trial
Comparison of Pre-Operative Versus Post-Operative Dexamethasone Administration on Post-Operative Complications in Lower Third Molar Surgery using Saline as a Control: A Randomized Clinical Trial with
Disease or Health Condition(s) Studied
Bony impacted lower third molars.
Scientific Acronym
CADA-LTM
Public Acronym
None
Brief title
Dexamethasone administration in lower third molar surgery.
Universal Trial Number
U1111-1313-2546
Any other number(s) assigned to the trial and issuing authority
ODC-2024-AS-203:Research & Innovation Committee, Oman
What is the research question being addressed?
How does preoperative versus postoperative administration of dexamethasone, compared to saline as a placebo affect postoperative complications in lower third molar surgery?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Healthcare providers
Control
Placebo
Assignment
Other
Purpose
Treatment
Study Phase
Phase 1
Intervention(s) planned
The study will be conducted in a clinical-based setting, specifically within the Department of Oral Surgery at Oman Dental College, located in Muscat, Oman.
Patients planned for lower third molar surgery will be recruited from the outpatient clinic of the Department of Oral Surgery and will be randomised to four groups using the [include random selection method] Intervention will be as follows
Four groups
Group 1: Patients receiving pre-operative normal saline
Group 2: Patients receiving pre-operative dexamethasone submucosal injections in 4mg
Group 3: Patients receiving post-operative saline
Group 4: Patients receiving post-operative dexamethasone submucosal injections in 4mg
Inclusion criteria
Inclusion Criteria: -
* All ages
* Both men and women
* Individuals officially diagnosed with lower bony impacted third molars. Diagonosis is according to winter’s classification (horizontal, vertical, mesioangular, distoangular). OPGs (orthopantomogram) will be taken for all participants. Using this radiograph, the type of impaction will be determined.
* Patients scheduled to undergo surgical extraction of bony impacted lower third molar surgery at the oral Surgery Department in Oman Dental College.
• 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 Post-operative symptoms following surgical removal of lower wisdom teeth Questionnaire.
Exclusion criteria
Exclusion Criteria:
• Patients who took pre-op antibiotics.
• Individuals with cognitive impairments that impede their ability to understand the consent process or to accurately fill out the questionnaires.
• Patients with None bony impaction that might affect the surgery's outcomes or their ability to participate fully in the study.
Primary outcome(s)
|
1.
1.Visual analogue scale: a modified validated Arabic version, consisting of 15 questions across 3 sections: pain, swelling and trismus. The score ranges from 0 to 5, with lower scores indicating better outcomes. |
[ [post surgery for 5 days on each day] ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
60. (15 per group)
Countries of recruitment
Oman
Anticipated start date
2025-01-22
Anticipated end date
2025-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Private
Regulatory approvals
Ethics, Research & Innovation Committee (ERIC), Oman Dental College, Muscat, Oman
Status
Approved
Date of Approval
2024-09-12
Approval number
ODC-2024-AS-203
Details of Ethics Review Committee
| Name: | Ethics, Research & Innovation Committee |
| 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 person for Scientific Queries/Principal Investigator
Amur Alsenaidi
Assistant Professor
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116
Sultanate of Oman
96894388846
96897647585
none
aalsenaidi@staff.odc.edu.om
none
Contact Person for Public Queries
Amur Alsenaidi
Assistant Professor
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116
Sultanate of Oman
96894388846
96897647585
none
aalsenaidi@staff.odc.edu.om
none
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not Applicable
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
