Back to results3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
Primary Purpose
Swelling/ Edema, Impacted Third Molar Tooth
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Piezo-electric surgery of impacted lower third molars
Rotary bur surgery of impacted lower third molars
Sponsored by
About this trial
This is an interventional treatment trial for Swelling/ Edema focused on measuring piezosurgery, conventional osteotomy, impacted lower third molar, facial scan, 3d rendering
Eligibility Criteria
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
Sites / Locations
- University Hospital Policlinic Gaetano Martino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Piezosurgery
Conventional bur
Arm Description
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur
Outcomes
Primary Outcome Measures
Facial swelling
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05488028
First Posted
August 2, 2022
Last Updated
August 3, 2022
Sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
1. Study Identification
Unique Protocol Identification Number
NCT05488028
Brief Title
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
Official Title
Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swelling/ Edema, Impacted Third Molar Tooth
Keywords
piezosurgery, conventional osteotomy, impacted lower third molar, facial scan, 3d rendering
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split-mouth model
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Piezosurgery
Arm Type
Experimental
Arm Description
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a piezo-electric instrument
Arm Title
Conventional bur
Arm Type
Experimental
Arm Description
Patients needing lower third molar surgery, in which the osteotomy is performed by the use of a drilling bur
Intervention Type
Procedure
Intervention Name(s)
Piezo-electric surgery of impacted lower third molars
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rotary bur surgery of impacted lower third molars
Intervention Description
During lower third molar surgery, osteotomy is performed using rotary instruments
Primary Outcome Measure Information:
Title
Facial swelling
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Policlinic Gaetano Martino
City
Messina
State/Province
Messina (ME)
ZIP/Postal Code
98124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
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