- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965855
- Original Trial
Effect of Piezoelectric Surgery onPostoperative Complications in Third Molar Surgery
Revolution or Routine? Assessing the Postoperative Impact of Piezoelectric Surgery on Edema, Trismus, and Other Complications in Third Molar Extractions
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 30 patients in the piezoelectric surgery group
|
Description: This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with piezoelectric surgery
|
|
Experimental: 30 patients in the conventional surgery group
|
This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with conventional surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Edema amounts with Routine and Piezoelectric Surgery
Time Frame: The edema measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.
|
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
Time Frame: The trismus measurements are made on the patient preoperatively and on the 2nd and 7th postoperative days.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wound healing, bleeding, infection, alveolitis, paresthesia, and temporomandibular joint pain with Routine and Piezoelectric Surgery
Time Frame: within 7 days after surgery
|
These complications are recorded by clinical examination.
|
within 7 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mert Zeytinoğlu, Ege University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EGE-DHF-MZ-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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