Impacted Mandibular Third Molar Extraction
Conditions
Keywords
submucosal dexamethasone, impacted mandibular third molar, surgical extraction, pain, swelling, trismus
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: Submucosal injection of 4mg/ml dexamethasone will result in lower mean postoperative pain, reduced trismus and less swelling after mandibular third molar surgery.
Interventions
DRUGDexamethasone
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
DRUGNormal Saline
submucosal injection of normal saline (N/S) would not reduce trismus, swelling, and pain
Sponsors
PAEC General Hospital, Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Study design: Randomized controlled trial (RCT). Setting: Department of Oral & Maxillofacial Surgery, Pakistan Atomic Energy Commission General Hospital, Islamabad. Duration: 12 months (after approval of synopsis from CPSP)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Cases of impacted mandibular third molar according to Pell and Gregory classification (class l, 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of post-operative pain, in patients who have undergone surgery for impacted mandibular third molars. | 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. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| demographic data (name, age, gender) | from enrolment to 7th post operative day | name, age, gender would be used to assess the effects of demographic data on post operative sequelae |
| tooth number of impacted tooth according to FDI tooth numbering system, type of impaction | from enrolment to 7th post operative day | 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. |
| No. of Paracetamol 500 mg tablets taken orally postoperatively | from enrolment to 7th post operative day | 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. |
Countries
Pakistan
Outcome results
None listed