- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06971653
- Original Trial
Effect of Piezoelectric Surgery on Pain, Comfort, and Patient Satisfaction in Third Molar Surgery
Piezoelectric Versus Conventional Surgical Approaches in Third Molar Removal: A Focus on Pain, Comfort, and Patient Satisfaction
The purpose of this study is to compare the effects of piezoelectric surgery on postoperative pain, comfort and patient satisfaction 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 pain and increasing comfort and patient satisfaction in impacted third molar surgery? Pain levels were assessed using the Visual Analog Scale (VAS), and patient satisfaction was measured with functional evaluations conducted on the 1st, 3rd, and 7th postoperative days.
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
|
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 |
|---|---|---|
|
Postoperative pain with Routine and Piezoelectric Surgery
Time Frame: The postoperative outcomes including pain are clinically assessed at different-time intervals (6th and 12th hours after the operation, 1st, 2nd, 3rd and 7th days after the operation).
|
The primary outcome measure is postoperative pain with Routine and Piezoelectric Surgery in bilateral impacted third molar.
Postoperative pain is assessed using the numbered and visual pain scale.
Patients are asked to mark the pain they felt on the scale days after the operation.
|
The postoperative outcomes including pain are clinically assessed at different-time intervals (6th and 12th hours after the operation, 1st, 2nd, 3rd and 7th days after the operation).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chewing, Swallowing and Speaking Functions with Routine and Piezoelectric Surgery
Time Frame: The postoperative outcomes including chewing, swallowing and speaking are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days postoperative days).
|
Starting from the first day of the operation until the 7th day when the stitches are removed, the patients mark their subjective complaints about their quality of life on the forms by giving them scores between 0 and 5, considering their chewing, swallowing and speaking functions.
(Patient Evaluation Form) These forms are evaluated and the patients' satisfaction with their quality of life is measured in the post-operative period.
|
The postoperative outcomes including chewing, swallowing and speaking are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days postoperative days).
|
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-004
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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