Tooth DiseaseGermectomyNCT06778590
Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar
A study testing Piezoelectric technique in third molar germectomy and Traditional technique in third molar germectomy in people with Tooth Disease and Piezoelectric Technique, run by Amerigo Giudice at 1 site in Italy.
Trial summary
The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Disease, Piezoelectric Technique, Tooth Impacted
- What is being tested?
- Piezoelectric technique in third molar germectomy and Traditional technique in third molar germectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons
- Good quality of radiographic investigations (CBCT)
- Good health status
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Magna Graecia University of Catanzaro
Catanzaro, 88100
Amerigo Giudice, Prof-MD-PhD, 09613647215, a.giudice@unicz.it
About this study
Official title: Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar: Assessment of Post-operative Sequelae
The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars
Read the detailed description
The main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. Post-operative swelling is analyzed using a photogrammetry facial scanner (Marathon MT-4000).
- Conditions
- Tooth Disease, Piezoelectric Technique, Tooth Impacted, Tooth Extraction Status Nos, Tooth Avulsion, Facial Swelling
- Being tested
- Piezoelectric technique in third molar germectomy, Traditional technique in third molar germectomy
- Keywords
- third molar surgery, facial swelling, 3D facial swelling evaluation, Piezoelectric technique, tooth impacted, piezosurgery, germectomy
- 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 technique in third molar germectomyProcedure or surgery
Application of piezoelectric technique in third molar germectomy procedures
Traditional technique in third molar germectomyProcedure or surgery
Application of traditional technique in third molar germectomy procedures
| Study group | Role | What they receive |
|---|---|---|
| Test group: Piezoelectric Surgery | Experimental | Use of piezoelectric technique in third molar germectomy procedures Receives: Procedure: Piezoelectric technique in third molar germectomy |
| Control group: Traditional Surgery | Active comparator | Use of traditional technique in third molar germectomy procedures Receives: Procedure: Traditional technique in third molar germectomy |
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 posted16 Jan 2025
- Study start1 Aug 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiseaseStudies 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
- 22 participants (estimated)
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
- NCT06778590
- Sponsor's protocol ID
- 372/2024
- Acronym
- Germectomy
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 16 Jan 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar: Assessment of Post-operative Sequelae
- ClinicalTrials.gov ID
- NCT06778590
- Acronym / sponsor ID
- Germectomy / 372/2024
- Conditions
- Tooth Disease, 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, germectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Amerigo GiudiceUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 16 Jan 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.
The main objective of the study is to compare the effects of the piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars
Detailed description
The main objective of the study is to compare the effects of piezoelectric surgery and the traditional technique on soft tissue edema in patients undergoing bilateral germectomy of mandibular third molars. Post-operative swelling is analyzed using a photogrammetry facial scanner (Marathon MT-4000).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group: Piezoelectric Surgery | Experimental | Procedure: Piezoelectric technique in third molar germectomyUse of piezoelectric technique in third molar germectomy procedures |
| Control group: Traditional Surgery | Active comparator | Procedure: Traditional technique in third molar germectomyUse of traditional technique in third molar germectomy procedures |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged between 14 and 24 years, with both lower third molars in the developmental stage (with incompletely formed roots) and requiring extraction of both for prophylactic, therapeutic or strategic reasons
- Good quality of radiographic investigations (CBCT)
- Good health status
Key exclusion criteria (0 listed)
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 technique in third molar germectomyApplication of piezoelectric technique in third molar germectomy procedures | Procedure or surgery | Test group: Piezoelectric Surgery |
| Traditional technique in third molar germectomyApplication of traditional technique in third molar germectomy procedures | Procedure or surgery | Control group: Traditional Surgery |
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 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.
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 technique in third molar germectomy and Traditional technique in third molar germectomy in people with Tooth Disease 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 3 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 16 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amerigo Giudice, Prof, MD, PhD (09613647215, a.giudice@unicz.it), or a site near the patient. 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?
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 16 Jan 2025.