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

Primary Purpose

Tooth, Impacted

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
piezo surgery
conventional surgery
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted focused on measuring piezolectric surgery, conventional surgery, lower third molars

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of Dental Medicine, University of Belgrade

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

healthy, conventional surgery

healthy, piezo surgery

Arm Description

Surgical bone removal by conventional rotary burs in healthy patients during third molar surgery

Surgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery

Outcomes

Primary Outcome Measures

SOD activity in alveolar bone specimen
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
VEGF levels in alveolar bone specimen
MMP-9 level in alveolar bone specimen

Secondary Outcome Measures

Full Information

First Posted
October 20, 2016
Last Updated
December 2, 2022
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT02942108
Brief Title
Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted
Keywords
piezolectric surgery, conventional surgery, lower third molars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy, conventional surgery
Arm Type
Active Comparator
Arm Description
Surgical bone removal by conventional rotary burs in healthy patients during third molar surgery
Arm Title
healthy, piezo surgery
Arm Type
Experimental
Arm Description
Surgical bone removal by piezoelectric vibrations in healthy patients during third molar surgery
Intervention Type
Procedure
Intervention Name(s)
piezo surgery
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Primary Outcome Measure Information:
Title
SOD activity in alveolar bone specimen
Description
Activity of enzyme superoxide dismutase in bone specimens obtained during lower third molar surgery
Time Frame
immediately after surgery
Title
VEGF levels in alveolar bone specimen
Time Frame
immediately after surgery
Title
MMP-9 level in alveolar bone specimen
Time Frame
immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bozidar M Brkovic, DDS,PhD
Organizational Affiliation
School of Dental Medicine, University of Belgrade
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Milan V Vucetic, PhD student
Organizational Affiliation
School of Dental Medicine, University of Belgrade
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marija S Milic, DDS, PhD
Organizational Affiliation
School of Dental Medicine, University of Belgrade
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dental Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32712962
Citation
Bailey E, Kashbour W, Shah N, Worthington HV, Renton TF, Coulthard P. Surgical techniques for the removal of mandibular wisdom teeth. Cochrane Database Syst Rev. 2020 Jul 26;7(7):CD004345. doi: 10.1002/14651858.CD004345.pub3.
Results Reference
derived

Learn more about this trial

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

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