NCT06212232

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

January 8, 2024

Last Update Submit

March 24, 2025

Conditions

Tooth DiseasesPiezoelectric TechniqueTooth, ImpactedTooth Extraction Status NosTooth AvulsionFacial Swelling

Keywords

third molar surgeryfacial swelling3D facial swelling evaluationPiezoelectric techniquetooth impactedpiezosurgery

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)

Experimental: Test Group

EXPERIMENTAL

Use of a new piezoelectric technique in third molar surgery

Procedure: Piezoelectric surgery

Traditional: Control Group

ACTIVE COMPARATOR

Use of the traditional technique in third molar surgery

Procedure: Piezoelectric surgery

Interventions

Piezoelectric surgeryPROCEDURE

Application of a new piezoelectric technique in third molar surgery

Experimental: Test GroupTraditional: Control Group

Eligibility Criteria

Age18 Years - 32 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Tooth DiseasesTooth, ImpactedTooth Avulsion

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesTooth InjuriesWounds and Injuries

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
Professor

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

July 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 24, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)