NCT07185620

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 9, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

Third molarPiezoelectricConventional Rotary SystemsPostoperative SequelaeOHIP-14

Outcome Measures

Primary Outcomes (4)

  • mouth opening measurement

    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.

    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.

    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.

    Oral health-related quality of life was evaluated using the OHIP-14. Participants completed the questionnaire preoperatively, and on postoperative days 2 and 7.

Study Arms (2)

Piezoelectric Surgery group

EXPERIMENTAL

The group in which osteotomy during third molar extraction was performed using a piezoelectric device.

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.

Procedure: Third molar surgery with Conventional Rotary System

Interventions

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.

Piezoelectric Surgery group

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.

Conventional Rotary Systems

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with systemic conditions such as
  • diabetes mellitus,
  • immunodeficiency,
  • bleeding disorders,
  • dyspepsia or
  • those classified as heavy smokers (over 10 cigarettes daily)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University, Faculty of Dentistry

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 39590403BACKGROUND
  • Erdem 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.

    PMID: 39272144BACKGROUND
  • Demirci 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.

    PMID: 37992138BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 22, 2025

Study Start

August 4, 2025

Primary Completion

September 5, 2025

Study Completion

September 8, 2025

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations