Clinical trial NCT05548049: Autogenous Ramus Bone Block Harvesting With Piezosurgery
Official title: A Prospective Randomized Trial Comparing Conventional And Piezosurgery Method In Mandibular Bone Block Harvesting From The Retromolar Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Resorption
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Osteotomy time
timeFrame: Intraoperative
Secondary outcomes:
measure: Change in pain
timeFrame: 7 days
measure: Change in Mouth opening
timeFrame: 7 days
measure: Change in Oral Health-related Quality of Life
timeFrame: 14 days
measure: Operation time
timeFrame: Intraoperative
measure: Change in facial swelling
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
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citation: Starch-Jensen T, Deluiz D, Deb S, Bruun NH, Tinoco EMB. Harvesting of Autogenous Bone Graft from the Ascending Mandibular Ramus Compared with the Chin Region: a Systematic Review and Meta-Analysis Focusing on Complications and Donor Site Morbidity. J Oral Maxillofac Res. 2020 Nov 30;11(3):e1. doi: 10.5037/jomr.2020.11301. eCollection 2020 Jul-Sep.
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