A Phase 4 interventional study of Dexamethasone and Normal Saline in Impacted Mandibular Third Molar Extraction, sponsored by PAEC General Hospital, Islamabad. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by PAEC General Hospital, Islamabad · Phase 4, Interventional, and Prevention
Purpose: The aim of this study is to determine the efficacy of submucosal injection of dexamethasone in reducing pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay. Moreover, the submucosal injection is convenient to the patient and surgeon both, as it is injected after application of local anesthesia and easily administered. OBJECTIVES: To evaluate the outcome of submucosal injection of 4mg/ml dexamethasone in comparison with submucosal injection of normal saline (N/S) on mean post-operative pain, trismus and swelling following mandibular third molar surgery.
OPERATIONAL DEFINITIONS:
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm) by marking a single point on the line.
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
Trismus: Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
HYPOTHESIS:
Submucosal injection of 4mg/ml dexamethasone will result in lower mean postoperative pain, reduced trismus and less swelling after mandibular third molar surgery.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →PAEC General Hospital, Islamabad is the lead sponsor of 9 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
submucosal injection of dexamethasone would be used in this study to prevent post-operative pain , swelling and trismus in patient having surgical extraction of impacted mandibular third molars.
Drug: Dexamethasone
Out of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo.
Drug: Normal Saline
In this study submucosal injection of dexamethasone would be given to the patient 30 minutes before surgical extraction of impacted mandibular third molar surgery to reduce pain, swelling and trismus, thus to minimize patient's discomfort after surgery, so that the patients could pursue their daily activities without delay
submucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.
Pain: Post-operative pain outcome when measured using Visual Analogue Scale (VAS) would determine the subjective pain experience of patients. VAS is a straight, 10 cm long horizontal line. VAS represents continuous pain intensity, where the left end of the line indicates "no pain," while the right end denotes "worst pain imaginable." Patients indicate their level of pain (in cm). by marking a single point on the line.
Time frame: from enrolment to 7th post operative day
measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.
Trismus i.e., reduced mouth opening would be quantified in millimeters by measuring interincisal distance at maximum mouth opening using a vernier caliper. Normal mouth opening ranges from 40 to 60 mm. Mouth opening less than 40 mm is considered trismus.
Time frame: From enrollment to the 7th Postoperative day
measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.
Swelling: Post-operative facial swelling would be assessed by using Gabka and Matsumara technique. Linear distance between angle of the mandible to lateral corner of the eye (A), distance between tragus to corner of the mouth (B), and distance between tragus to soft tissue pogonion (C) would be quantified in millimeters using measuring tape. The sum of these measurements would be calculated as facial dimension and used to measure the level of swelling in millimeters.
Time frame: from enrolment to 7th post operative day
demographic data (name, age, gender)
name, age, gender would be used to assess the effects of demographic data on post operative sequelae
Time frame: from enrolment to 7th post operative day
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction
tooth number of impacted tooth according to FDI tooth numbering system, type of impaction according to pell and gregory classification would be used to assess any effect of these outcomes on post-operative sequelae after mandibular third molar surgery.
Time frame: from enrolment to 7th post operative day
No. of Paracetamol 500 mg tablets taken orally postoperatively
No. of Paracetamol 500 mg tablets taken orally postoperatively would be used to assess if patient was pain free or had pain post-operatively following impacted mandibular third molar surgery.
Time frame: from enrolment to 7th post operative day
Plan to share: No — As the hospital where this study is being conducted does allow to share any collected data with other researchers due to patient confidentiality
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
PAEC General Hospital, Islamabad