Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery

December 2, 2022 updated by: Bozidar Brkovic, DDS, MSc, PhD, Professor, University of Belgrade
The aim of this clinical trial is to investigate and compare the effect of piezoelectric surgery on tissue, cellular and molecular level of oral surgical wound healing and postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • School of dental medicine, University of Belgrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilaterally symmetrically impacted lower third molars

Exclusion Criteria:

  • presence of intraoral infection
  • chronic orofacial pain
  • pregnancy/ lactation
  • heavy tobacco smokers
  • alcohol/ drug abuse
  • allergic reaction to medicaments used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: healthy, conventional surgery
Surgical bone removal by conventional rotary burs in healthy patients during third molar surgery
Procedure: conventional surgery
Experimental: healthy, piezo surgery
Surgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery
Procedure: piezo surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SOD activity in alveolar bone specimen
Time Frame: immediately after surgery
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
immediately after surgery
VEGF levels in alveolar bone specimen
Time Frame: immediately after surgery
immediately after surgery
MMP-9 level in alveolar bone specimen
Time Frame: immediately after surgery
immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Belgrade

Investigators

  • Principal Investigator: Bozidar M Brkovic, DDS,PhD, School of dental medicine, University of Belgrade
  • Principal Investigator: Milan V Vucetic, PhD student, School of dental medicine, University of Belgrade
  • Principal Investigator: Marija S Milic, DDS, PhD, School of dental medicine, University of Belgrade

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36/20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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