Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery

Piezo-surgery Technique and Intramuscular Dexamethasone Injection to Reduce Postoperative Pain After Impacted Mandibular Third Molar Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Impacted Mandibular Third Molar Extraction
• Intervention / Treatment: Procedure: Conventional Rotatory instruments; Drug: Dexamethasone injection; Procedure: Piezosurgery

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 1100
    • Central Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotatory Instruments without Dexamethasone injection; Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection	Procedure: Conventional Rotatory instruments; Surgical extraction using conventional rotatory instruments to perform osteotomy
Experimental: Rotatory Instruments with Dexamethasone injection; Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery	Drug: Dexamethasone injection; Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery
Experimental: Piezosurgery technique without Dexamethasone injection; Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection	Procedure: Conventional Rotatory instruments; Surgical extraction using conventional rotatory instruments to perform osteotomy; Procedure: Piezosurgery; Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery
Experimental: Piezosurgery technique with Dexamethasone injection; Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery	Drug: Dexamethasone injection; Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery; Procedure: Piezosurgery; Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Postoperative Pain level From Baseline	Postoperative Pain level using Visual Analogue Scale (VAS): 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain	Days 1, 3, and 7 Post-op
Working time	Surgery time from the start of the incision until the end of the suturing (min).	Per-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change oh The maximal mouth opening From Baseline	The maximal mouth opening, previously taken at Day 0 was measured at day three post-op, and expressed in millimeters (mm).	At Day 0 and Day 3

Collaborators and Investigators

• Sponsor: Central Military Healthcare - Oral and Maxillofacial Surgery Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 9, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Dexamethasone; Piezosurgery; Impacted Mandibular Third molar surgery.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Pain, Postoperative; Tooth, Impacted; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dexamethasone acetate
• Other Study ID Numbers: REF 16/02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No