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

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino" (Other)

Overall Status

Completed

CT.gov ID

NCT05488028

Collaborator

(none)

Enrollment

Location

Arms

7.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Swelling/ Edema Impacted Third Molar Tooth	Procedure: Piezo-electric surgery of impacted lower third molars Procedure: Rotary bur surgery of impacted lower third molars	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Split-mouth modelSplit-mouth model

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Facial swelling [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Policlinic Gaetano Martino	Messina	Messina (ME)	Italy	98124

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

ClinicalTrials.gov Identifier:

NCT05488028

Other Study ID Numbers:

01-20

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda Ospedaliera Universitaria Policlinico "G. Martino"

piezosurgery

conventional osteotomy

impacted lower third molar

facial scan

3d rendering

Additional relevant MeSH terms:

Tooth, Impacted

Study Results

No Results Posted as of Aug 4, 2022