Tooth DiseasesNCT06212232
A New Piezoelectric Technique in Third Molar Surgery
A study testing Piezoelectric surgery in people with Tooth Diseases and Piezoelectric Technique, run by Amerigo Giudice at 1 site in Italy.
Trial summary
The present study aims to analyze the effect of the piezoelectric technique in third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Diseases, Piezoelectric Technique, Tooth, Impacted
- What is being tested?
- Piezoelectric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2023to 24 Mar 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 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 32 years who required both M3M extractions were recruited
- Good health status
- Indication to surgical extraction of both M3M
- Complete root formation
- Surgical risk level classified as "Conventional" or "Moderate" according to - Daugela et al. classification
Who cannot join
- Person under the age of 18 or over 32
- Allergy or contraindications to administration of corticosteroids
- Acute infection in any of the teeth to be extracted
- Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
- Pregnancy or breastfeeding
- History of treatment with antiresorptive drugs
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a New Piezoelectric Technique in Third Molar Surgery and Evaluation of Postoperative Sequelae: a Randomized Split-mouth
The present study aims to analyze the effect of the piezoelectric technique in third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial
Read the detailed description
The present study aims to analyze the effect of of the piezoelectric technique n third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.
- Conditions
- Tooth Diseases, Piezoelectric Technique, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion, Facial Swelling
- Being tested
- Piezoelectric surgery
- Keywords
- third molar surgery, facial swelling, 3D facial swelling evaluation, Piezoelectric technique, tooth impacted, piezosurgery
- Medical subject headings
- Tooth Diseases, Tooth, Impacted, Tooth Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezoelectric surgeryProcedure or surgery
Application of a new piezoelectric technique in third molar surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Test Group | Experimental | Use of a new piezoelectric technique in third molar surgery Receives: Procedure: Piezoelectric surgery |
| Traditional: Control Group | Active comparator | Use of the traditional technique in third molar surgery Receives: Procedure: Piezoelectric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial swelling qualitative analysis
To compare the effectiveness of piezosurgery in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - volumetric differences
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) .
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - linear differences
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) .
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes (2)
Trismus analysis
To assess the effects of piezosurgery on trismus (measured in cm)
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)
To assess the effects of piezosurgery on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome.
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jul 2023
- Primary completion1 Jan 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amerigo Giudice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amerigo Giudice, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212232
- Sponsor's protocol ID
- 123/2023
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antonelli A, Brunello G, Salviati M, Barone S, Bennardo F, Jones JM, Giudice A. Piezosurgery-assisted protocol for impacted mandibular third molar removal with 3D facial swelling analysis: a randomized split-mouth clinical trial on post-surgical sequelae. Clin Oral Investig. 2026 Jun 18;30(7):294. doi: 10.1007/s00784-026-06982-w.
PubMed 42310125
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Piezoelectric Technique in Third Molar Surgery and Evaluation of Postoperative Sequelae: a Randomized Split-mouth
- ClinicalTrials.gov ID
- NCT06212232
- Acronym / sponsor ID
- 123/2023
- Conditions
- Tooth Diseases, Piezoelectric Technique, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion, Facial Swelling
- Keywords
- third molar surgery, facial swelling, 3D facial swelling evaluation, Piezoelectric technique, tooth impacted, piezosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Amerigo GiudiceUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 18 Jan 2024 (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.
The present study aims to analyze the effect of the piezoelectric technique in third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial
Detailed description
The present study aims to analyze the effect of of the piezoelectric technique n third molar surgery in terms of facial swelling, trismus and pain in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Test Group | Experimental | Procedure: Piezoelectric surgeryUse of a new piezoelectric technique in third molar surgery |
| Traditional: Control Group | Active comparator | Procedure: Piezoelectric surgeryUse of the traditional technique in third molar surgery |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 32 years who required both M3M extractions were recruited
- Good health status
- Indication to surgical extraction of both M3M
- Complete root formation
- Surgical risk level classified as "Conventional" or "Moderate" according to - Daugela et al. classification
Key exclusion criteria (7 listed)
- Person under the age of 18 or over 32
- Allergy or contraindications to administration of corticosteroids
- Acute infection in any of the teeth to be extracted
- Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Piezoelectric surgeryApplication of a new piezoelectric technique in third molar surgery | Procedure or surgery | Experimental: Test Group, Traditional: Control Group |
Primary outcome
Facial swelling qualitative analysis
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .
Facial swelling quantitative analysis - volumetric differences
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) .
Facial swelling quantitative analysis - linear differences
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
To compare the effectiveness of piezosurgery in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) .
2 secondary outcomes
Trismus analysis
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after 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 27 Mar 2025.
- Derived from this study: PubMed 42310125Antonelli A, Brunello G, Salviati M, Barone S, Bennardo F, Jones JM, Giudice A. Piezosurgery-assisted protocol for impacted mandibular third molar removal with 3D facial swelling analysis: a randomized split-mouth clinical trial on post-surgical sequelae. Clin Oral Investig. 2026 Jun 18;30(7):294. doi: 10.1007/s00784-026-06982-w.
- 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 Piezoelectric surgery in people with Tooth Diseases and Piezoelectric Technique, run by Amerigo Giudice at 1 site in Italy.
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 5 inclusion and 7 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 27 Mar 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 Italy. 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?
Facial swelling qualitative analysis (time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212232, which also lists 1 linked publication.
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 27 Mar 2025.