ClinicalTrials.gg
CompletedNCT06212232Updated Mar 27, 2025

A New Piezoelectric Technique in Third Molar Surgery

An interventional study of Piezoelectric surgery in Tooth Diseases, Piezoelectric Technique and Tooth, Impacted, sponsored by Amerigo Giudice. Completed at 1 site in Italy. Open to participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.

Primary conditionTooth, ImpactedRegistry: Tooth DiseasesReclassifiedWhy we changed it
Registry
Tooth Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Tooth, Impacted
Why
  1. The study's listed conditions name Tooth, Impacted, a narrower term within Tooth Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Amerigo Giudice · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2023, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 32 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tooth Diseases
  • Piezoelectric Technique
  • Tooth, Impacted
  • Tooth Extraction Status Nos
  • Tooth Avulsion
  • Facial Swelling

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Keywords

  • third molar surgery
  • facial swelling
  • 3D facial swelling evaluation
  • Piezoelectric technique
  • tooth impacted
  • piezosurgery
03

In context

Tooth, Impacted Reclassified

122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.

This study's enrollment of 47 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Amerigo Giudice is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Compared within Tooth, Impacted, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tooth Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 32 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Person under the age of 18 or over 32
  • Allergy or to administration of
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Experimental: Test Group

    Use of a new piezoelectric technique in third molar surgery

    Procedure: Piezoelectric surgery

  • Active comparator
    Traditional: Control Group

    Use of the traditional technique in third molar surgery

    Procedure: Piezoelectric surgery

Interventions

  • ProcedurePiezoelectric surgery

    Application of a new piezoelectric technique in third molar surgery

06

What researchers measure

Primary outcomes

  1. 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) .

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

  2. 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) .

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

  3. 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) .

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary outcomes

  1. Trismus analysis

    To assess the effects of piezosurgery on trismus (measured in cm)

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

  2. 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.

    Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

07

Study locations

1 site
  • Magna Graecia University of Catanzaro
    Catanzaro, 88100, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Jan 2025, 18 months.

Of 55 non-industry interventional studies with no phase under Tooth, Impacted, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 18 months is close to that.

Counting every sponsor, half of 56 studies reached it within 20 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2024
First posted
Jan 18, 2024
StartActual
Jul 1, 2023
Primary completionActual
Jan 1, 2025
CompletionActual
Mar 24, 2025
Last update
Mar 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06212232
Lead sponsor
Amerigo Giudice
Responsible party
Amerigo Giudice (Professor, University Magna Graecia) — Sponsor-investigator
First posted
Jan 18, 2024
Start date
Jul 1, 2023
Primary completion
Jan 1, 2025
Completion
Mar 24, 2025
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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