NCT06965855

Brief Summary

The purpose of this study is to compare the effects of piezoelectric surgery on postoperative edema, trismus and other postoperative complications (Wound Healing, Bleeding, Infection, Alveolitis, Paresthesia) with conventional bur method applied in surgical extraction of impacted mandibular third molars. The main question it aims to answer is: Is piezoelectric surgery effective on reducing the edema, trismus and other postoperative complications (Wound Healing, Bleeding, Infection, Alveolitis, Paresthesia) in impacted third molar surgery? Postoperative edema measurements are determined at 24 hours, 48 hours, and 7 days using the flexible ruler method. Trismus is determined by measuring the interincisal distance. Statistical analyses are performed to compare the two surgical methods.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 11, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 25, 2025

Last Update Submit

May 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Edema amounts with Routine and Piezoelectric Surgery

    Edema measurements are made on the distances between the corner of the eye and the angulus mandible, between the tragus and the corner of the mouth, and between the tragus and the soft tissue pogonium. These points were marked with a dermatological pen and measured with the flexible ruler method.

    The edema measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.

  • Trismus amounts with Routine and Piezoelectric Surgery

    In order to determine the trismus, the values of the mouth openings of the patients are obtained by measuring the distance between the mesial corners of the first permanent incisors in the upper and lower jaws with the help of a caliper (Mitutoyo Company, Japan) with a sensitivity of 0.05.

    The trismus measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.

Secondary Outcomes (1)

  • Wound healing, bleeding, infection, alveolitis, paresthesia, and temporomandibular joint pain with Routine and Piezoelectric Surgery

    within 7 days after surgery

Study Arms (2)

30 patients in the piezoelectric surgery group

EXPERIMENTAL
Procedure: piezoelectric surgery

30 patients in the conventional surgery group

EXPERIMENTAL
Procedure: conventional surgery

Interventions

This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with conventional surgery

30 patients in the conventional surgery group

Description: This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with piezoelectric surgery

30 patients in the piezoelectric surgery group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with mesioangular, distoangular, vertical or horizontal, fully impacted and fully bone retained impacted lower wisdom teeth
  • Patients without any systemic disease
  • Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.

You may not qualify if:

  • Patients with any systemic contraindication, infection in the area of the tooth to be extracted, anamnesis of sensitivity to paracetamol derivatives or aspirin, pregnant or breastfeeding patients, and patients using antibiotics or anti-inflammatory drugs in the last 3 weeks
  • In addition, smokers or alcohol addicts were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mert Zeytinoğlu

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 11, 2025

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

January 1, 2013

Last Updated

May 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share