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

Study Overview
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Brief Summary
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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

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

Conditions
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Swelling/ Edema, Impacted Third Molar Tooth

Intervention / Treatment
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* Procedure: Piezo-electric surgery of impacted lower third molars
* Procedure: Rotary bur surgery of impacted lower third molars


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth model
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezosurgery<br>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<br>* 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.<br>|
| Experimental: Conventional bur<br>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<br>* During lower third molar surgery, osteotomy is performed using rotary instruments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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piezosurgery, conventional osteotomy, impacted lower third molar, facial scan, 3d rendering