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| ID | Type | Description | Link |
|---|---|---|---|
| 1428/ĐHYD-HĐĐĐ | Other Identifier | Institutional Review Board, University of Medicine and Pharmacy at Ho Chi Minh City |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic Device (Piezosurgery) | Experimental | 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. |
|
| Conventional Rotary Instruments | Active Comparator | Surgical extraction of impacted mandibular third molars using conventional rotary instruments. Clinical outcomes (pain, swelling, trismus) and salivary hsCRP levels will be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic Device (Piezosurgery) | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Postoperative swelling |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City, Faculty of Dentistry | Ho Chi Minh City | 700000 | Vietnam |
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| Conventional rotary instruments | Device | 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. |
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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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D014313 | Trismus |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059745 | Piezosurgery |
| ID | Term |
|---|---|
| D059708 | Ultrasonic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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