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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04889781
Enrollment
80
Registered
2021-05-17
Start date
2019-02-01
Completion date
2019-07-01
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Mandibular Third Molar Extraction

Keywords

Impacted Mandibular Third molar surgery., Pain, Dexamethasone, Piezosurgery

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.

Interventions

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

PROCEDUREPiezosurgery

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

PROCEDUREConventional Rotatory instruments

Surgical extraction using conventional rotatory instruments to perform osteotomy

Sponsors

Central Military Healthcare - Oral and Maxillofacial Surgery Department
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Postoperative Pain level From BaselineDays 1, 3, and 7 Post-opPostoperative 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 timePer-opSurgery time from the start of the incision until the end of the suturing (min).

Secondary

MeasureTime frameDescription
Change oh The maximal mouth opening From BaselineAt Day 0 and Day 3The maximal mouth opening, previously taken at Day 0 was measured at day three post-op, and expressed in millimeters (mm).

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026