Autogenous Ramus Bone Block Harvesting With Piezosurgery

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized prospective clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the Conventional and Piezosurgery Method. The study was planned on 19 patients (13F,6M) on 31 donor sites. In patients with bilateral bone harvesting, the donor site and the surgical method to be used were determined by the randomization protocol, while in patients with bone harvesting from a single site, the donor site was determined by considering parameters such as proximity to the operation site and distance to the inferior alveolar nerve. Clinical parameters such as operation time, pain, swelling, trismus, nerve damage were evaluated.

Official Title
-----------------
A Prospective Randomized Trial Comparing Conventional And Piezosurgery Method In Mandibular Bone Block Harvesting From The Retromolar Region

Conditions
-----------------
Alveolar Bone Resorption

Intervention / Treatment
-----------------
* Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation
* Device: Bone harvesting from ramus area with conventional burs for autogenous bone augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II The main inclusion criteria were severe alveolar ridge atrophy in the horizontal plane (≤4 mm) and no accompanying vertical defect, according to preoperative CBCT scans. 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 Donor field in the mouth of another region (simfiz, tuber etc.) or any extra-oral field is planned to be used Patients with cleft lip-palate or defect exceeding the alveolar crest Grafts applied to defects caused by tumors, osteoradionecrosis, or congenital malformations Patients with an unstable systemic condition such as metabolic bone disease, uncontrolled diabetes, or untreated hypothyroidism, as well as smokers, patients undergoing radiation therapy or chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 piezosurgical device was used to harvest the bone block from the ramus area. | Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation<br>* In this invervention, the piezo-surgical device settings were set to irrigation: '4', function: 'cortical', light: 'auto'. After the full-thickness flap was lifted with the periosteal elevator, superior and vertical osteotomies were performed with the OT-12 piezo-surgical tip. Lower horizontal osteotomies were performed using OT8-L or OT-8-R piezo tips according to the studied quadrant, combining the vertical osteotomy.<br>|
| Active Comparator: Conventional Group<br>In the experimental group, a conventional burr was used to harvest the bone block from the ramus area. | Device: Bone harvesting from ramus area with conventional burs for autogenous bone augmentation<br>* In control group, After the full-thickness flap is lifted with the periosteal elevator, using a thin #9 fissure burand the surgical handpiece S-11 Straight tip , the physiodispenser settings are according to the manufacturer's recommendations. The osteotomy was performed after it was adjusted to 40,000 rpm as appropriate. Bone incisions were completed with a round bur to combine the lower horizontal osteotomies and 2 vertical osteotomies. The osteotomies were completed with the help of a thin flat drill, and the block graft was carefully separated from the donor site.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteotomy time | The time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch. | Intraoperative | 

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 | 
| Change in Oral Health-related Quality of Life | Evaluated by OHIP-14 | 14 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 |