Study Stopped
There was a change in the protocol of the study
Betamethasone and Complications of Lower Third Molar Surgery
Effect of Betamethasone Injection Into the Pterygomandibular Space on Postoperative Sequelae of Impacted Lower Third Molar Surgery: A Randomized, Double-blind, Placebo-controlled Clinical Trial With a Split-mouth Design
1 other identifier
interventional
40
1 country
1
Brief Summary
Pain, swelling, and trismus are common sequalae of surgical removal of impacted third molars. The aim of this study is to evaluate effect of local administration of betamethasone, into the pterygomandibular space, on these sequalae
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2022
Shorter than P25 for phase_3
1 active site
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 Start
First participant enrolled
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2023
CompletedFirst Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
December 22, 2025
CompletedDecember 22, 2025
December 1, 2025
1.1 years
April 19, 2023
December 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain was assessed by patient self-report using a visual analogue scale (VAS; 0-10), where 0 indicated no pain and 10 indicated the worst imaginable pain.
postoperative pain assessed by the patient on VAS pain score
Pain scores were recorded immediately after surgery and daily for the first five days
Secondary Outcomes (2)
trismus
Trismus was measured on the first, third, and seventh postoperative days
Facial swelling
Facial swelling was measured on the first, third, and seventh postoperative days
Study Arms (2)
betamethasone treated side
EXPERIMENTALBetamethasone was administered into the pterygomandibular space immediately before surgery
Control side
PLACEBO COMPARATORnormal saline was administered into the pterygomandibular space immediately before surgery
Interventions
The study group (group I) received 1 ml (6 mg) of betamethasone (CKOÇAK FARMA, Turkey) injection to the pterygomandibular space. Each ml contains 3.0 mg betamethasone acetate and 3.0 mg betamethasone sodium phosphate
Eligibility Criteria
You may qualify if:
- healthy
- no infection
- no pain
- no limitation of mouth opening
- symmetrical bilateral impacted third molars (Mesioangular, CLASS II, Position B
You may not qualify if:
- Infection
- systemic disease
- smokers
- operation time exceeding 30 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shehab Ahmed Hamad
Erbil, 00441, Iraq
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shehab Hamad, FFDRCSI
Kurdistan Higher Council of Medical Specialties
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assisstan professor
Study Record Dates
First Submitted
April 19, 2023
First Posted
December 22, 2025
Study Start
January 3, 2022
Primary Completion
February 21, 2023
Study Completion
March 26, 2023
Last Updated
December 22, 2025
Record last verified: 2025-12