NCT07196904

Ultrasonic vs Rotary Instruments in Impacted Mandibular Third Molar Surgery: Clinical and Salivary CRP Outcomes

A Randomized Controlled Clinical Trial Evaluating the Effectiveness of Ultrasonic Device in Impacted Mandibular Third Molar Surgery: Assessment Through Clinical Indices and Salivary C-reactive Protein Levels

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Le Huynh Thien An · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

In the surgical removal of impacted mandibular third molars, ultrasonic surgical devices (piezosurgery) have been introduced with the expectation of reducing postoperative complications such as swelling, pain, and trismus, compared with conventional rotary instruments. To objectively evaluate the postoperative inflammatory response, salivary high-sensitivity C-reactive protein (hsCRP), a reliable biomarker of acute inflammation, will also be measured. This randomized controlled clinical trial is designed to compare the effectiveness of ultrasonic surgery and conventional rotary instruments in impacted mandibular third molar extraction. The study has two primary objectives: * To compare clinical outcomes, including swelling, mouth opening limitation, and pain, on postoperative days 2 and 5 between the two surgical methods. * To assess changes in salivary hsCRP levels by comparing preoperative baseline values with postoperative day 2 values, and to determine differences between the two surgical techniques. A total of 22 patients indicated for bilateral impacted mandibular third molar extractions of similar difficulty will be enrolled. Each patient will undergo one extraction using ultrasonic surgery and the contralateral extraction using rotary instruments, in a randomized split-mouth design. Pain and swelling will be assessed on postoperative days 2 and 5. Saliva samples will be collected preoperatively and on postoperative day 2 for hsCRP analysis using enzyme-linked immunosorbent assay (ELISA). The hypothesis is that ultrasonic surgery will result in reduced pain, swelling, and limitation of mouth opening, as well as lower salivary hsCRP levels, compared with conventional rotary instruments. Findings from this study may provide scientific evidence supporting the use of ultrasonic devices to improve patient outcomes and may highlight the role of salivary hsCRP as a non-invasive biomarker for monitoring inflammation after oral surgery.

Conditions

• Impacted Mandibular Third Molar
• Pain
• Swelling
• Trismus
• Inflammation

Interventions

Type	Name	Description
DEVICE	Ultrasonic Device (Piezosurgery)	Mandibular impacted third molar extraction performed with an ultrasonic surgical device. The piezosurgery device was used exclusively for the osteotomy (bone removal) stage, while conventional rotary instruments were still used for tooth sectioning when required. This selective approach aimed to evaluate whether piezosurgery could reduce surgical trauma compared to full rotary techniques.
DEVICE	Conventional rotary instruments	Mandibular impacted third molar extraction performed entirely with conventional rotary instruments. Both bone removal and tooth sectioning were conducted using high-speed rotary instruments under continuous irrigation. This served as the control arm to compare with the ultrasonic-assisted technique.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-05-31
• Completion: 2025-08-31
• First posted: 2025-09-29
• Last updated: 2025-10-01

Locations

1 site across 1 country: Vietnam