CompletedNot Applicable

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

Vietnam22 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Salivary hsCRP concentration

Timeframe: Preoperative (baseline) and day 2 after surgery

Trial details

NCT IDNCT07196904

SponsorLe Huynh Thien An

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Impacted Mandibular Third Molar trials