Oral ComplicationNCT06965855
Effect of Piezoelectric Surgery onPostoperative Complications in Third Molar Surgery
A study testing conventional surgery and piezoelectric surgery in people with Oral Complication, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Complication
- What is being tested?
- conventional surgery and piezoelectric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Oral Complication
- Being tested
- conventional surgery, piezoelectric surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with conventional surgery
piezoelectric surgeryProcedure or surgery
Description: This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with piezoelectric surgery
| Study group | Role | What they receive |
|---|---|---|
| 30 patients in the piezoelectric surgery group | Experimental | Not described Receives: Procedure: piezoelectric surgery |
| 30 patients in the conventional surgery group | Experimental | Not described Receives: Procedure: conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
These complications are recorded by clinical examination.
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jan 2012
- Primary completion1 Jun 2012
- Study completion1 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral ComplicationStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Zeytinoğlu, Ege University
- Investigators
- Mert Zeytinoğlu, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965855
- Sponsor's protocol ID
- EGE-DHF-MZ-003
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revolution or Routine? Assessing the Postoperative Impact of Piezoelectric Surgery on Edema, Trismus, and Other Complications in Third Molar Extractions
- ClinicalTrials.gov ID
- NCT06965855
- Acronym / sponsor ID
- EGE-DHF-MZ-003
- Conditions
- Oral Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 patients in the piezoelectric surgery group | Experimental | Procedure: piezoelectric surgery |
| 30 patients in the conventional surgery group | Experimental | Procedure: conventional surgery |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgeryThis retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with conventional surgery | Procedure or surgery | 30 patients in the conventional surgery group |
| piezoelectric surgeryDescription: This retrospective clinical study included 30 patients who underwent extraction of impacted lower third molars with piezoelectric surgery | Procedure or surgery | 30 patients in the piezoelectric surgery group |
Primary outcome
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.
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.
1 secondary outcome
Wound healing, bleeding, infection, alveolitis, paresthesia, and temporomandibular joint pain with Routine and Piezoelectric Surgery
Time frame: within 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mert Zeytinoğlu principal investigator
Ege University
Questions about this trial
What is this clinical trial studying?
A study testing conventional surgery and piezoelectric surgery in people with Oral Complication, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.