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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-24
SponsorAmerigo Giudice

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Piezoelectric technique in third molar germectomy

    Procedure/Surgery

    Application of piezoelectric technique in third molar germectomy procedures

  • Traditional technique in third molar germectomy

    Procedure/Surgery

    Application of traditional technique in third molar germectomy procedures

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Test group: Piezoelectric SurgeryExperimental treatment 1 intervention
Group B: Control group: Traditional SurgeryActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amerigo Giudice

Lead sponsor

University Magna Graecia

Sponsor institution