An interventional study of Ultrasonic Device (Piezosurgery) and Conventional rotary instruments in Impacted Mandibular Third Molar, Pain and Swelling, sponsored by Le Huynh Thien An. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Le Huynh Thien An · Not applicable, Interventional, and Treatment
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:
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 22 is below the median of 66 across 8,493 interventional studies indexed under Pain.
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Exclusion Criteria:
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)
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 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.
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.
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.
Time frame: Preoperative (baseline) and day 2 after 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).
Time frame: Day 2 and Day 5 post-surgery.
Postoperative swelling
Change in extraoral facial dimensions measured at specific anatomical landmarks
Time frame: Day 2 and Day 5 post-surgery
Mouth opening (trismus)
Change in maximum interincisal distance (mm)
Time frame: Day 2 and Day 5 post-surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in May 2025, 8 months.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 8 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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