ClinicalTrials.gg
RecruitingNCT06778590GermectomyUpdated Jan 16, 2025

Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar

An interventional study of Piezoelectric technique in third molar germectomy and Traditional technique in third molar germectomy in Tooth Disease, Piezoelectric Technique and Tooth Impacted, sponsored by Amerigo Giudice. Recruiting at 1 site in Italy. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-16.

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

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Aug 2024, registered Jan 2025).
  • Started Aug 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
14 Years to 24 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Tooth Disease
  • Piezoelectric Technique
  • Tooth Impacted
  • Tooth Extraction Status Nos
  • Tooth Avulsion
  • Facial Swelling
  • Germectomy

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Keywords

  • third molar surgery
  • facial swelling
  • 3D facial swelling evaluation
  • Piezoelectric technique
  • tooth impacted
  • piezosurgery
  • germectomy
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 planned enrollment of 22 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
14 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

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

Study arms

  • Experimental
    Test group: Piezoelectric Surgery

    Use of piezoelectric technique in third molar germectomy procedures

    Procedure: Piezoelectric technique in third molar germectomy

  • Active comparator
    Control group: Traditional Surgery

    Use of traditional technique in third molar germectomy procedures

    Procedure: Traditional technique in third molar germectomy

Interventions

  • ProcedurePiezoelectric technique in third molar germectomy

    Application of piezoelectric technique in third molar germectomy procedures

  • ProcedureTraditional technique in third molar germectomy

    Application of traditional technique in third molar germectomy procedures

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 of 1 sites recruiting
  • Magna Graecia University of Catanzaro
    Catanzaro, 88100, Italy
    Recruiting
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

Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.

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 planned 12 months is below 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 12, 2025
First posted
Jan 16, 2025
StartActual
Aug 1, 2024
Primary completionEst.
Aug 31, 2025
CompletionEst.
Oct 31, 2025
Last update
Jan 16, 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 Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06778590
Lead sponsor
Amerigo Giudice
Responsible party
Amerigo Giudice (Amerigo Giudice, University Magna Graecia) — Sponsor-investigator
First posted
Jan 16, 2025
Start date
Aug 1, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Oct 31, 2025 (estimated)
Last update
Jan 16, 2025

Study contacts

Amerigo Giudice, Prof, MD, PhD
Contact
a.giudice@unicz.it
09613647215

Oversight

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

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