Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.

Official Title
-----------------
A Randomized Split Mouth Clinical Trial Comparing Piezosurgery and Conventional Rotary Instruments on Impacted Third Molar Surgery

Conditions
-----------------
Impacted Third Molar Tooth

Intervention / Treatment
-----------------
* Device: Piezosurgery
* Device: Conventional burs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II Aged 18-35 Symmetrical Class 2 Position B according to Winter and Pell-gregory classification Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index Exclusion Criteria: Individuals who had systemic disease affecting bone or soft tissue metabolism Smokers (more than 10 cigarettes a day Alcohol dependent Systemic disease affecting bone or soft tissue metabolism Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Piezosurgery group<br>In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar. | Device: Piezosurgery<br>* Piezosurgery used as an osteotomy device<br>|
| Active Comparator: Conventional group<br>In the control group, conventional burs were used to remove the bone surrounding the impacted third molar. | Device: Conventional burs<br>* Conventional burs used as an osteotomy device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oral Health-related Quality of Life | Evaluated by OHIP-14 | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable | 7 days | 
| Change in Mouth opening | The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum. | 7 days | 
| Operation time | The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time. | Intraoperative | 
| Change in facial swelling | With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impacted Tooth, Piezo-Electric Surgery, Postoperative Complication