A New Piezoelectric Technique in Third Molar Surgery

Not Applicable

Completed

• Conditions: Tooth, Impacted; Tooth Extraction Status Nos; Facial Swelling; Tooth Avulsion; Tooth Diseases; Piezoelectric Technique
• Interventions: Procedure: Piezoelectric surgery

• Registration Number: NCT06212232
• Lead Sponsor: Amerigo Giudice

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

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.

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-18
• Primary Completion: 2025-01-01
• Status Verified: 2025-03
• Study Completion: 2025-03-24
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Test Group	Piezoelectric surgery	Use of a new piezoelectric technique in third molar surgery
Traditional: Control Group	Piezoelectric surgery	Use of the traditional technique in third molar surgery

Primary Outcome Measures

Name	Time	Method
Facial swelling quantitative analysis - linear differences	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) .
Facial swelling quantitative analysis - volumetric differences	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 qualitative analysis	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) .

Secondary Outcome Measures

Name	Time	Method
Trismus analysis	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery	To assess the effects of piezosurgery on trismus (measured in cm)
Pain analysis with Visual analogue scale (VAS)	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery	To assess the effects of piezosurgery on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome.

Trial Locations

Locations (1)

Magna Graecia University of Catanzaro; 🇮🇹 Catanzaro, Italy