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

Primary Purpose

Impacted Mandibular Third Molar Extraction

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Dexamethasone injection
Piezosurgery
Conventional Rotatory instruments
Sponsored by
Central Military Healthcare - Oral and Maxillofacial Surgery Department
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Mandibular Third Molar Extraction focused on measuring Impacted Mandibular Third molar surgery., Pain, Dexamethasone, Piezosurgery

Eligibility Criteria

15 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Central Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Rotatory Instruments without Dexamethasone injection

Rotatory Instruments with Dexamethasone injection

Piezosurgery technique without Dexamethasone injection

Piezosurgery technique with Dexamethasone injection

Arm Description

Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular 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

Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection

Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
May 9, 2021
Last Updated
May 14, 2021
Sponsor
Central Military Healthcare - Oral and Maxillofacial Surgery Department
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1. Study Identification

Unique Protocol Identification Number
NCT04889781
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Military Healthcare - Oral and Maxillofacial Surgery Department

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Mandibular Third Molar Extraction
Keywords
Impacted Mandibular Third molar surgery., Pain, Dexamethasone, Piezosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotatory Instruments without Dexamethasone injection
Arm Type
Experimental
Arm Description
Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy without Intramuscular Dexamethasone injection
Arm Title
Rotatory Instruments with Dexamethasone injection
Arm Type
Experimental
Arm Description
Surgical extraction of Impacted Mandibular Third Molar using conventional rotatory instruments to perform osteotomy with 8 mg Intramuscular Dexamethasone injection 30 min before surgery
Arm Title
Piezosurgery technique without Dexamethasone injection
Arm Type
Experimental
Arm Description
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique without Intramuscular Dexamethasone injection
Arm Title
Piezosurgery technique with Dexamethasone injection
Arm Type
Experimental
Arm Description
Surgical extraction of Impacted Mandibular Third Molar using the piezosurgery technique with 8 mg Intramuscular Dexamethasone injection 30 min before surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone injection
Intervention Description
Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery
Intervention Type
Procedure
Intervention Name(s)
Piezosurgery
Intervention Description
Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery
Intervention Type
Procedure
Intervention Name(s)
Conventional Rotatory instruments
Intervention Description
Surgical extraction using conventional rotatory instruments to perform osteotomy
Primary Outcome Measure Information:
Title
Change of Postoperative Pain level From Baseline
Description
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
Time Frame
Days 1, 3, and 7 Post-op
Title
Working time
Description
Surgery time from the start of the incision until the end of the suturing (min).
Time Frame
Per-op
Secondary Outcome Measure Information:
Title
Change oh The maximal mouth opening From Baseline
Description
The maximal mouth opening, previously taken at Day 0 was measured at day three post-op, and expressed in millimeters (mm).
Time Frame
At Day 0 and Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Central Military Hospital
City
Beirut
ZIP/Postal Code
1100
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34380473
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.
Results Reference
derived

Learn more about this trial

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

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