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Completed

NCT Number: NCT04889781

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

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.

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Key information

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Military Hospital

Beirut, 1100, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone Injection

Drug

Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery

Piezosurgery

Procedure

Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery

Conventional Rotatory instruments

Procedure

Surgical extraction using conventional rotatory instruments to perform osteotomy

Primary outcomes

  1. Change of Postoperative Pain level From Baseline

    Time frame: Days 1, 3, and 7 Post-op

    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

  2. Working time

    Time frame: Per-op

    Surgery time from the start of the incision until the end of the suturing (min).

Secondary outcomes

  1. Change oh The maximal mouth opening From Baseline

    Time frame: At Day 0 and Day 3

    The maximal mouth opening, previously taken at Day 0 was measured at day three post-op, and expressed in millimeters (mm).

Sponsors and collaborators

Lead sponsor

Central Military Healthcare - Oral and Maxillofacial Surgery Department

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 17, 2021
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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