Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT07185620
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Piezoelectric and Conventional Rotary Techniques in Third Molar Surgery: Postoperative Outcomes and Quality of Life
Sponsor:
Izzet Acikan
Organization:
Study Overview
Official Title:
Effects of Impacted Mandibular Third Molar Surgery Performed With Piezoelectric and Conventional Rotary Systems on Postoperative Sequelae and Quality of Life
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: