Third Molar ExtractionNCT07185620
Piezoelectric and Conventional Rotary Techniques in Third Molar Surgery: Postoperative Outcomes and Quality of Life
A study testing Third molar surgery with piezoelectric system and Third molar surgery with Conventional Rotary System in people with Third Molar Extraction and Piezoelectric Technique, run by Izzet Acikan at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized clinical trial comparing recovery after the surgical removal of impacted lower wisdom teeth. The aim is to evaluate swelling, pain, mouth opening, and quality of life after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third Molar Extraction, Piezoelectric Technique
- What is being tested?
- Third molar surgery with piezoelectric system and Third molar surgery with Conventional Rotary System
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 8 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having an indication for impacted third molar extraction in the mandible,
- absence of acute pericoronitis or any other active infection,
- willingness to participate in the study.
Who cannot join
- Individuals with systemic conditions such as
- diabetes mellitus,
- immunodeficiency,
- bleeding disorders,
- dyspepsia or
- those classified as heavy smokers (over 10 cigarettes daily)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University, Faculty of Dentistry
Kahramanmaraş
About this study
Official title: Effects of Impacted Mandibular Third Molar Surgery Performed With Piezoelectric and Conventional Rotary Systems on Postoperative Sequelae and Quality of Life
This study is a prospective, randomized clinical trial comparing recovery after the surgical removal of impacted lower wisdom teeth. The aim is to evaluate swelling, pain, mouth opening, and quality of life after surgery.
The study was approved by the Ethics Committee of Harran University, and all patients gave written informed consent. It was conducted at the Faculty of Dentistry, Kahramanmaraş Sütçü İmam University. A total of 50 patients participated. They were randomly assigned to two groups: one treated with a piezoelectric device (study group) and the other with a conventional rotary handpiece (control group). All surgeries were performed by the same surgeon under local anesthesia.
Read more
In both groups, the tooth was removed, the bone edges were smoothed, the area was cleaned with sterile solution, and the gum flap was closed with stitches. In the piezoelectric group, the bone was removed using an ultrasonic piezoelectric system. In the conventional group, bone removal was performed with a surgical drill under irrigation.
After surgery, patients were followed for pain, swelling, mouth opening, and quality of life. Pain was measured daily for 7 days using a 10-point visual scale (0 = no pain, 10 = worst pain). Mouth opening was measured before surgery, on the 2nd day, and on the 7th day after surgery. Swelling was measured using 3-dimensional facial scans taken before surgery, and on the 2nd and 7th days after surgery. Quality of life was assessed with a short questionnaire (OHIP-14), completed before surgery and on days 2, and 7 after surgery. Higher scores meant a worse impact on daily life.
- Conditions
- Third Molar Extraction, Piezoelectric Technique
- Being tested
- Third molar surgery with piezoelectric system, Third molar surgery with Conventional Rotary System
- Keywords
- Third molar, Piezoelectric, Conventional Rotary Systems, Postoperative Sequelae, OHIP-14
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Third molar surgery with piezoelectric systemProcedure or surgery
For the surgical removal of the third molar with a mucoperiosteal flap, osteotomy was performed using a piezoelectric system under continuous irrigation. The mucoperiosteal flap was then repositioned and closed primarily with sutures.
Third molar surgery with Conventional Rotary SystemProcedure or surgery
For the surgical removal of the third molar with a mucoperiosteal flap, osteotomy was performed using a conventional rotary system under continuous irrigation. The mucoperiosteal flap was then repositioned and closed primarily with sutures.
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric Surgery group | Experimental | The group in which osteotomy during third molar extraction was performed using a piezoelectric device. Receives: Procedure: Third molar surgery with piezoelectric system |
| Conventional Rotary Systems | Active comparator | The group in which osteotomy during third molar extraction was performed using a conventional rotary system. Receives: Procedure: Third molar surgery with Conventional Rotary System |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth opening measurement
Measured: Maximum mouth opening measurements were performed at three different time points: before surgery, on the 2nd postoperative day, and on the 7th postoperative day, and were recorded in millimeters.
Pain Assessment
The patients' pain levels were evaluated using a 10-unit Visual Analog Scale (VAS). The patients were given a form on which they could mark the pain they felt as a score between 0 (no pain) and 10 (the most severe pain) at the following time points: 20 minutes before local anesthesia administration, and on postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7. After completing these forms, the patients returned them at the end of the 7th day.
Measured: Preoperative 20 minutes before local anesthesia administration, postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7.
swelling measurement
To objectively evaluate postoperative facial swelling, a 3D facial scanning method was employed. All facial scans were performed in the same room, with a standardized position and similar lighting conditions. To obtain three-dimensional facial images, the Qlone application (EyeCue Vision Technologies LTD.) running on an iPhone 14 device equipped with TrueDepth technology was used. This smartphone-based application provides a guided scanning procedure that enables a rapid and detailed capture of the patient's face. At the end of each scanning session, an STL file representing the patient's facial structure was generated. The obtained STL-format facial models were imported into the 3D imaging software 3D Slicer. T0 and T1/T2 facial scans were superimposed within 3D Slicer to detect changes occurring in the facial surface. The superimposition process was carried out using surface registration, referencing stable anatomical regions of the face.
Measured: For the measurement of swelling, each patient underwent three-dimensional facial scanning at three time points: immediately before surgery (T0), on the 2nd postoperative day (T1), and on the 7th postoperative day (T2).
Quality of Life Assessment
Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. The OHIP-14 assessment was performed preoperatively, and on postoperative days 2 and 7. Each question was rated on a 4-point scale: 1 = "never," 2 = "sometimes," 3 = "fairly often," and 4 = "very often." The possible total score ranged from 0 to 56, with higher scores reflecting greater impairment in quality of life.
Measured: Oral health-related quality of life was evaluated using the OHIP-14. Participants completed the questionnaire preoperatively, and on postoperative days 2 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start4 Aug 2025
- Primary completion5 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Third Molar ExtractionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izzet Acikan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Izzet Acikan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185620
- Sponsor's protocol ID
- HRÜ/25.07.46
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cantore S, Silva FFVE, Bizzoca ME, Smimmo A, Lo Muzio L, Vianna Camolesi GC, Perez-Sayans M, Ballini A. Enhancing Lower Third Molar Surgery: Using The Piezoelectric Technique for Superior Postoperative Outcomes and Complication Prevention. Dent J (Basel). 2024 Nov 1;12(11):353. doi: 10.3390/dj12110353.
PubMed 39590403Erdem MK, Cambazoglu M. A comparative analysis of postoperative morbidity and alveolar bone regeneration following surgical extraction of impacted lower third molar teeth using piezosurgery and conventional instruments: a split-mouth clinical investigation. Eur J Med Res. 2024 Sep 14;29(1):460. doi: 10.1186/s40001-024-02051-8.
PubMed 39272144Demirci A, Bayram F, Dergin G. Piezosurgery versus conventional rotary surgery for impacted third molars: A randomised, split-mouth, clinical pilot trial. Med Oral Patol Oral Cir Bucal. 2024 Jan 1;29(1):e1-e8. doi: 10.4317/medoral.25929.
PubMed 37992138
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Impacted Mandibular Third Molar Surgery Performed With Piezoelectric and Conventional Rotary Systems on Postoperative Sequelae and Quality of Life
- ClinicalTrials.gov ID
- NCT07185620
- Acronym / sponsor ID
- HRÜ/25.07.46
- Conditions
- Third Molar Extraction, Piezoelectric Technique
- Keywords
- Third molar, Piezoelectric, Conventional Rotary Systems, Postoperative Sequelae, OHIP-14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Izzet AcikanUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 22 Sep 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.
This study is a prospective, randomized clinical trial comparing recovery after the surgical removal of impacted lower wisdom teeth. The aim is to evaluate swelling, pain, mouth opening, and quality of life after surgery.
The study was approved by the Ethics Committee of Harran University, and all patients gave written informed consent. It was conducted at the Faculty of Dentistry, Kahramanmaraş Sütçü İmam University. A total of 50 patients participated. They were randomly assigned to two groups: one treated with a piezoelectric device (study group) and the other with a conventional rotary handpiece (control group). All surgeries were performed by the same surgeon under local anesthesia.
In both groups, the tooth was removed, the bone edges were smoothed, the area was cleaned with sterile solution, and the gum flap was closed with stitches. In the piezoelectric group, the bone was removed using an ultrasonic piezoelectric system. In the conventional group, bone removal was performed with a surgical drill under irrigation.
After surgery, patients were followed for pain, swelling, mouth opening, and quality of life. Pain was measured daily for 7 days using a 10-point visual scale (0 = no pain, 10 = worst pain). Mouth opening was measured before surgery, on the 2nd day, and on the 7th day after surgery. Swelling was measured using 3-dimensional facial scans taken before surgery, and on the 2nd and 7th days after surgery. Quality of life was assessed with a short questionnaire (OHIP-14), completed before surgery and on days 2, and 7 after surgery. Higher scores meant a worse impact on daily life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezoelectric Surgery group | Experimental | Procedure: Third molar surgery with piezoelectric systemThe group in which osteotomy during third molar extraction was performed using a piezoelectric device. |
| Conventional Rotary Systems | Active comparator | Procedure: Third molar surgery with Conventional Rotary SystemThe group in which osteotomy during third molar extraction was performed using a conventional rotary system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- having an indication for impacted third molar extraction in the mandible,
- absence of acute pericoronitis or any other active infection,
- willingness to participate in the study.
Key exclusion criteria (6 listed)
- Individuals with systemic conditions such as
- diabetes mellitus,
- immunodeficiency,
- bleeding disorders,
- dyspepsia or
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 |
|---|---|---|
| Third molar surgery with piezoelectric systemFor the surgical removal of the third molar with a mucoperiosteal flap, osteotomy was performed using a piezoelectric system under continuous irrigation. The mucoperiosteal flap was then repositioned and closed primarily with sutures. | Procedure or surgery | Piezoelectric Surgery group |
| Third molar surgery with Conventional Rotary SystemFor the surgical removal of the third molar with a mucoperiosteal flap, osteotomy was performed using a conventional rotary system under continuous irrigation. The mucoperiosteal flap was then repositioned and closed primarily with sutures. | Procedure or surgery | Conventional Rotary Systems |
Primary outcome
mouth opening measurement
Time frame: Maximum mouth opening measurements were performed at three different time points: before surgery, on the 2nd postoperative day, and on the 7th postoperative day, and were recorded in millimeters.
Pain Assessment
Time frame: Preoperative 20 minutes before local anesthesia administration, postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7.
The patients' pain levels were evaluated using a 10-unit Visual Analog Scale (VAS). The patients were given a form on which they could mark the pain they felt as a score between 0 (no pain) and 10 (the most severe pain) at the following time points: 20 minutes before local anesthesia administration, and on postoperative day 1, day 2, day 3, day 4, day 5, day 6, and day 7. After completing these forms, the patients returned them at the end of the 7th day.
swelling measurement
Time frame: For the measurement of swelling, each patient underwent three-dimensional facial scanning at three time points: immediately before surgery (T0), on the 2nd postoperative day (T1), and on the 7th postoperative day (T2).
To objectively evaluate postoperative facial swelling, a 3D facial scanning method was employed. All facial scans were performed in the same room, with a standardized position and similar lighting conditions. To obtain three-dimensional facial images, the Qlone application (EyeCue Vision Technologies LTD.) running on an iPhone 14 device equipped with TrueDepth technology was used. This smartphone-based application provides a guided scanning procedure that enables a rapid and detailed capture of the patient's face. At the end of each scanning session, an STL file representing the patient's facial structure was generated. The obtained STL-format facial models were imported into the 3D imaging software 3D Slicer. T0 and T1/T2 facial scans were superimposed within 3D Slicer to detect changes occurring in the facial surface. The superimposition process was carried out using surface registration, referencing stable anatomical regions of the face.
Quality of Life Assessment
Time frame: Oral health-related quality of life was evaluated using the OHIP-14. Participants completed the questionnaire preoperatively, and on postoperative days 2 and 7.
Quality of life was evaluated before and after surgery using the OHIP-14 questionnaire. The OHIP-14 assessment was performed preoperatively, and on postoperative days 2 and 7. Each question was rated on a 4-point scale: 1 = "never," 2 = "sometimes," 3 = "fairly often," and 4 = "very often." The possible total score ranged from 0 to 56, with higher scores reflecting greater impairment in quality of life.
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 22 Sep 2025.
- Results publication: PubMed 39590403Cantore S, Silva FFVE, Bizzoca ME, Smimmo A, Lo Muzio L, Vianna Camolesi GC, Perez-Sayans M, Ballini A. Enhancing Lower Third Molar Surgery: Using The Piezoelectric Technique for Superior Postoperative Outcomes and Complication Prevention. Dent J (Basel). 2024 Nov 1;12(11):353. doi: 10.3390/dj12110353.
- Results publication: PubMed 39272144Erdem MK, Cambazoglu M. A comparative analysis of postoperative morbidity and alveolar bone regeneration following surgical extraction of impacted lower third molar teeth using piezosurgery and conventional instruments: a split-mouth clinical investigation. Eur J Med Res. 2024 Sep 14;29(1):460. doi: 10.1186/s40001-024-02051-8.
- Results publication: PubMed 37992138Demirci A, Bayram F, Dergin G. Piezosurgery versus conventional rotary surgery for impacted third molars: A randomised, split-mouth, clinical pilot trial. Med Oral Patol Oral Cir Bucal. 2024 Jan 1;29(1):e1-e8. doi: 10.4317/medoral.25929.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Third molar surgery with piezoelectric system and Third molar surgery with Conventional Rotary System in people with Third Molar Extraction and Piezoelectric Technique, run by Izzet Acikan at 1 site in Turkey (Türkiye).
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 6 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
mouth opening measurement (time frame: Maximum mouth opening measurements were performed at three different time points: before surgery, on the 2nd postoperative day, and on the 7th postoperative day, and were recorded in millimeters.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07185620, which also lists 3 linked publications.
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 22 Sep 2025.