Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments

February 8, 2024 updated by: Murat Kaan Erdem, Ankara University

Comparative Evaluation of Morbidity and Alveolar Bone Healing After Surgical Extraction of Impacted Lower Third Molar Teeth Using Piezosurgery and Conventional Instruments: A Split-Mouth Clinical Study

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

Detailed Description

The aim of our study is to comparatively evaluate the duration of the operation and the pain, trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical extractions of impacted lower third molar teeth using piezosurgery and traditional rotary instruments.

Study Type

Interventional

Enrollment (Actual)

21

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
    • Çankaya
      • Ankara, Çankaya, Turkey, 06510
        • Ankara University Faculty 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

  • Adult

Accepts Healthy Volunteers

Yes

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.

Intervention: Device: Piezosurgery
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.

Intervention: Device: Conventional burs
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: Time Frame: 14 days
Evaluated by Oral Health Impact Profile-14 questionnaire (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.
Time Frame: 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

Ankara University

Investigators

  • Study Director: Murat K Erdem, PhD, DDS, Ankara University Faculty of Dentistry

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)

November 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Murat Kaan Erdem

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
  • 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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