Impacted Mandibular Third MolarPiezoCRPNCT07196904
Ultrasonic vs Rotary Instruments in Impacted Mandibular Third Molar Surgery: Clinical and Salivary CRP Outcomes
A study testing Ultrasonic Device (Piezosurgery) and Conventional rotary instruments in people with Impacted Mandibular Third Molar and Pain, run by Le Huynh Thien An at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Impacted Mandibular Third Molar, Pain, Swelling
- What is being tested?
- Ultrasonic Device (Piezosurgery) and Conventional rotary instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City, Faculty of Dentistry
Ho Chi Minh City, 700000
About this study
Official title: 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:
Read more
- 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
- Being tested
- Ultrasonic Device (Piezosurgery), Conventional rotary instruments
- Medical subject headings
- Pain, Trismus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional rotary instrumentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasonic Device (Piezosurgery) |
| 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. Receives: Device: Conventional rotary instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative (baseline) and day 2 after surgery
Secondary outcomes (3)
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).
Measured: Day 2 and Day 5 post-surgery.
Postoperative swelling
Change in extraoral facial dimensions measured at specific anatomical landmarks
Measured: Day 2 and Day 5 post-surgery
Mouth opening (trismus)
Change in maximum interincisal distance (mm)
Measured: Day 2 and Day 5 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Sep 2024
- Primary completion31 May 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Mandibular Third MolarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Huynh Thien An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Le Huynh Thien An, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196904
- Sponsor's protocol ID
- Piezo-CRP-2025
- Other IDs
- 1428/ĐHYD-HĐĐĐ
- Acronym
- PiezoCRP
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07196904
- Acronym / sponsor ID
- PiezoCRP / Piezo-CRP-2025
- Conditions
- Impacted Mandibular Third Molar, Pain, Swelling, Trismus, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Le Huynh Thien AnUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Device (Piezosurgery) | Experimental | Device: 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. |
| Conventional Rotary Instruments | Active comparator | Device: Conventional rotary instrumentsSurgical extraction of impacted mandibular third molars using conventional rotary instruments. Clinical outcomes (pain, swelling, trismus) and salivary hsCRP levels will be assessed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Ultrasonic Device (Piezosurgery) |
| Conventional rotary instrumentsMandibular 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. | Device | Conventional Rotary Instruments |
Primary outcome
Salivary hsCRP concentration
Time frame: Preoperative (baseline) and day 2 after surgery
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.
3 secondary outcomes
Postoperative pain
Time frame: Day 2 and Day 5 post-surgery.
Postoperative swelling
Time frame: Day 2 and Day 5 post-surgery
Mouth opening (trismus)
Time frame: Day 2 and Day 5 post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Device (Piezosurgery) and Conventional rotary instruments in people with Impacted Mandibular Third Molar and Pain, run by Le Huynh Thien An at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary hsCRP concentration (time frame: Preoperative (baseline) and day 2 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.