NCT06778590

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 12, 2025

Last Update Submit

January 15, 2025

Conditions

Tooth DiseasePiezoelectric TechniqueTooth ImpactedTooth Extraction Status NosTooth AvulsionFacial SwellingGermectomy

Keywords

third molar surgeryfacial swelling3D facial swelling evaluationPiezoelectric techniquetooth impactedpiezosurgerygermectomy

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

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

Secondary Outcomes (2)

  • Trismus analysis

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

  • Pain analysis with Visual analogue scale (VAS)

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

Study Arms (2)

Test group: Piezoelectric Surgery

EXPERIMENTAL

Use of piezoelectric technique in third molar germectomy procedures

Procedure: Piezoelectric technique in third molar germectomy

Control group: Traditional Surgery

ACTIVE COMPARATOR

Use of traditional technique in third molar germectomy procedures

Procedure: Traditional technique in third molar germectomy

Interventions

Piezoelectric technique in third molar germectomyPROCEDURE

Application of piezoelectric technique in third molar germectomy procedures

Test group: Piezoelectric Surgery
Traditional technique in third molar germectomyPROCEDURE

Application of traditional technique in third molar germectomy procedures

Control group: Traditional Surgery

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

MeSH Terms

Conditions

Tooth DiseasesTooth, ImpactedTooth Avulsion

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesTooth InjuriesWounds and Injuries

Central Study Contacts

Amerigo Giudice, Prof, MD, PhD

CONTACT

09613647215a.giudice@unicz.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Amerigo Giudice

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 16, 2025

Study Start

August 1, 2024

Primary Completion

August 31, 2025

Study Completion

October 31, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)