Clinical trial NCT04889781: Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery
Official title: Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Mandibular Third Molar Extraction
Keywords: Impacted Mandibular Third molar surgery.
Pain
Dexamethasone
Piezosurgery
Lead sponsor: Central Military Healthcare - Oral and Maxillofacial Surgery Department
Sponsor class: OTHER_GOV
First posted: 2021-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of my study is to test the effect of using piezosurgery and dexamethasone injection in the surgical extraction of impacted mandibular third molars, on Postoperative Pain.

Detailed description: Background: Third molar surgery is the most common procedure performed in oral and maxillofacial surgery practice.

This procedure is always associated with varying degrees of postoperative pain and swelling that may have a social impact. Traditionally, rotating instruments like burs have been used for osseous surgery.

Piezosurgery is a novel technique introduced to overcome the disadvantages associated with the conventional rotatory technique. Corticosteroids administration before or after the extraction of third molars is an efficient way to minimize postoperative pain due to their strong anti-inflammatory activity.

Many researchers conducted studies comparing the piezosurgery technique with conventional rotatory technique, regarding postoperative pain and working time, or studies comparing the conventional method with or without dexamethasone injection. Only one recent study (Nov 2018), conducted by Gümrükçü Z. et al. has compared Piezosurgery and dexamethasone injection in third molar surgery, but without evaluating the combined effect of these two techniques on postoperative pain.

Objectives: The objective of this study is to assess the effects of piezosurgery technique and intramuscular dexamethasone injection on postoperative pain in impacted third molar surgery.

Methods: The study design is a randomized controlled clinical trial: 80 patients with mandibular third molar impaction, indicated for surgical extraction should be treated randomly using either the piezosurgery or the conventional rotatory technique, and with or without intramuscular dexamethasone injection. Postoperative pain will be assessed using a visual analog scale (VAS) on days 1, 3, and seven postoperatively.

The differences in Post-operative pain within and between study groups (4 groups) will be tested using repeated measures of analysis of variance (ANOVA) or Friedman tests. Differences in working time among the three techniques will be assessed using a repeated measure of ANOVA. All statistical tests will be two-sided, and the significant level will be set at 0.05. All the analysis will be conducted using the Statistical Package for Social Sciences (SPSS) software version 22.

Eligibility criteria: Inclusion Criteria:

* Age from 15 to 30 years,
* Having mandibular impacted third molars,

Exclusion Criteria:

* Heavy smokers (≥20 cigarettes),
* Uncontrolled systemic conditions,
* Infection of the surgery site,
* Psychological problems,
* History of allergy to dexamethasone, amoxicillin, or acetaminophen.

Primary outcomes:
measure: Change of Postoperative Pain level From Baseline
timeFrame: Days 1, 3, and 7 Post-op
measure: Working time
timeFrame: Per-op
Secondary outcomes:
measure: Change oh The maximal mouth opening From Baseline
timeFrame: At Day 0 and Day 3
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Central Military Hospital
Study officials:
References:
citation: Nehme W, Fares Y, Abou-Abbas L. Piezo-surgery technique and intramuscular dexamethasone injection to reduce postoperative pain after impacted mandibular third molar surgery: a randomized clinical trial. BMC Oral Health. 2021 Aug 11;21(1):393. doi: 10.1186/s12903-021-01759-x.