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NCT Number: NCT06778590

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

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

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Key information

Conditions

Tooth Disease Facial Swelling Germectomy Piezoelectric Technique Stomatognathic Diseases Tooth Avulsion Tooth Diseases Tooth Extraction Status Nos Tooth Impacted Tooth Injuries Tooth, Impacted Wounds and Injuries

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magna Graecia University of Catanzaro

Catanzaro, 88100, Italy

Location status: Recruiting

Location contact

Amerigo Giudice, Prof-MD-PhD

CONTACT

[email protected]

09613647215

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piezoelectric technique in third molar germectomy

Procedure

Application of piezoelectric technique in third molar germectomy procedures

Traditional technique in third molar germectomy

Procedure

Application of traditional technique in third molar germectomy procedures

Primary outcomes

  1. Facial swelling qualitative analysis

    Time frame: 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)

  2. Facial swelling quantitative analysis - volumetric differences

    Time frame: 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)

  3. Facial swelling quantitative analysis - linear differences

    Time frame: 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)

Secondary outcomes

  1. Trismus analysis

    Time frame: 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)

  2. Pain analysis with Visual analogue scale (VAS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amerigo Giudice, Prof, MD, PhD

CONTACT

[email protected]

09613647215

Sponsors and collaborators

Lead sponsor

Amerigo Giudice

Other

Registry information

Official study title

Comparison of Piezoelectric and Conventional Surgery for Germectomy of the Lower Third Molar: Assessment of Post-operative Sequelae

Acronym: Germectomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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