Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

December 12, 2022 updated by: Ferit Bayram, Marmara University

A Randomized Split Mouth Clinical Trial Comparing Piezosurgery and Conventional Rotary Instruments on Impacted Third Molar Surgery

The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Turkey
      • Istanbul, Turkey, 34854
        • Marmara University School of Dentistry

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

14 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • Aged 18-35
  • Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
  • Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index

Exclusion Criteria:

  • Individuals who had systemic disease affecting bone or soft tissue metabolism
  • Smokers (more than 10 cigarettes a day
  • Alcohol dependent
  • Systemic disease affecting bone or soft tissue metabolism
  • Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Piezosurgery group
In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar.
Device: Piezosurgery
Piezosurgery used as an osteotomy device
Active Comparator: Conventional group
In the control group, conventional burs were used to remove the bone surrounding the impacted third molar.
Device: Conventional burs
Conventional burs used as an osteotomy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Health-related Quality of Life
Time Frame: 14 days
Evaluated by OHIP-14
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: 7 days
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable
7 days
Change in Mouth opening
Time Frame: 7 days
The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.
7 days
Operation time
Time Frame: Intraoperative
The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.
Intraoperative
Change in facial swelling
Time Frame: 7 days

With the technique described by Neupert ;

  • Angle of mandible-tragus
  • Angle of mandible-lateral canthus of eye
  • Mandible corner-nose wing
  • Angle of mandible oral-commissures
  • Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.
7 days

Collaborators and Investigators

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

Sponsor

Marmara University

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, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Estimate)

December 14, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUDHF_FB_0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Data will become available in 1 month and will be available for 2 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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