Submucosal Injection of Dexamethasone for the Control of Post-operative Sequelae After Mandibular Third Molar Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cases of impacted mandibular third molar according to Pell and Gregory classification (class l,
- •3 and A. B, C)
- •Both genders (male and female)
- •Age limit: 18 - 45 years
Exclusion Criteria
- •Patients with pericoronitis.
- •Patients with known allergy to corticosteroids.
- •Medically compromised patients.
- •Current pregnancy.
- •Lactating women.
- •Use of medication by the patients that could interfere with the healing process.
Arms & Interventions
Dexamethasone
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.
Intervention: Dexamethasone (Drug)
Normal saline (placebo)
Out of 70 patients 35 patients would be given submucosal injection of normal saline as a placebo.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars.
Time Frame: from enrolment to 7th post operative day
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.
measurement of post-operative trismus in patients who have undergone surgery for impacted mandibular third molars.
Time Frame: From enrollment to the 7th Postoperative day
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.
measurement of post-operative swelling in patients who have undergone surgery for impacted mandibular third molars.
Time Frame: from enrolment to 7th post operative day
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.
Secondary Outcomes
- demographic data (name, age, gender)(from enrolment to 7th post operative day)
- tooth number of impacted tooth according to FDI tooth numbering system, type of impaction(from enrolment to 7th post operative day)
- No. of Paracetamol 500 mg tablets taken orally postoperatively(from enrolment to 7th post operative day)
Investigators
Kanza Ateeque
Postgraduate Trainee Dr Kanza Ateeque
PAEC General Hospital, Islamabad