3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT

August 3, 2022 updated by: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial

Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Messina (ME)
      • Messina, Messina (ME), Italy, 98124
        • University Hospital Policlinic Gaetano Martino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • good general health conditions;
  • presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

Exclusion Criteria:

  • no clinical evidence of major facial asymmetry;
  • use of medication that would influence or alter wound healing;
  • temporomandibular joint disorder history;
  • smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Piezosurgery
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument
Procedure: Piezo-electric surgery of impacted lower third molars

During lower third molar surgery, osteotomy is performed using piezoelectric instrumentation.

When necessary, tooth sectioning was performed with a high-speed tungsten carbide slit drill under saline irrigation and the tooth removed in single or multiple segments.
EXPERIMENTAL: Conventional bur
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur
Procedure: Rotary bur surgery of impacted lower third molars
During lower third molar surgery, osteotomy is performed using rotary instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial swelling
Time Frame: 7 days

T0-T1 and T0-T2 scans are opened and superimposed through three reference points:

endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella).

After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (ACTUAL)

August 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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