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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation; Trismus; Swelling; Impacted Mandibular Third Molar
• Intervention / Treatment: Device: Ultrasonic Device (Piezosurgery); Device: Conventional rotary instruments

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • University of Medicine and Pharmacy at Ho Chi Minh City, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy patients (ASA Physical Status index ≤ 2), aged 18-35 years.
• Patients presenting with bilateral impacted mandibular third molars of comparable difficulty, with the angulation difference between the two teeth not exceeding 15 degrees, as assessed according to the Pell and Gregory classification on panoramic radiographs.
• Patients who agree to participate in the study after being fully informed about the objectives and requirements.

Exclusion Criteria:

• Patients with acute systemic or oral infection at the surgical sites.
• Patients with clinical evidence of tumors or cystic lesions, or radiolucent lesions larger than 3 mm on radiographs at the mandibular third molar site.
• Patients with a history of antibiotic or anti-inflammatory drug use within 3 weeks prior to study participation.
• Patients with psychiatric disorders, motor dysfunction, or trauma in the maxillofacial region.
• Patients with systemic diseases or medication use that reduces salivary secretion, such as Sjögren's syndrome or prior head and neck radiotherapy.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasonic Device (Piezosurgery); Surgical extraction of impacted mandibular third molars using an ultrasonic surgical device (piezosurgery). Clinical outcomes (pain, swelling, trismus) and salivary hsCRP levels will be assessed.	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.
Active Comparator: Conventional Rotary Instruments; Surgical extraction of impacted mandibular third molars using conventional rotary instruments. Clinical outcomes (pain, swelling, trismus) and salivary hsCRP levels will be assessed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary hsCRP concentration	High-sensitivity C-reactive protein (hsCRP) levels in saliva measured by ELISA assay. Baseline value before surgery will be compared with postoperative Day 2 levels to assess inflammatory response between groups.	Preoperative (baseline) and day 2 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative swelling	Change in extraoral facial dimensions measured at specific anatomical landmarks	Day 2 and Day 5 post-surgery
Mouth opening (trismus)	Change in maximum interincisal distance (mm)	Day 2 and Day 5 post-surgery
Postoperative pain	Change in patient-reported pain intensity using a 10-point Visual Analog Scale (VAS), range 0-10, 0 = no pain, 10 = worst imaginable pain).	Day 2 and Day 5 post-surgery.

Collaborators and Investigators

• Sponsor: Le Huynh Thien An

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: September 20, 2025
• First Posted (Estimated): September 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Spasm; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Inflammation; Trismus; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Piezosurgery
• Other Study ID Numbers: Piezo-CRP-2025; 1428/ĐHYD-HĐĐĐ (Other Identifier: Institutional Review Board, University of Medicine and Pharmacy at Ho Chi Minh City)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No