Autogenous Ramus Bone Block Harvesting With Piezosurgery
- Conditions
- Alveolar Bone Resorption
- Interventions
- Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentationDevice: Bone harvesting from ramus area with conventional burs for autogenous bone augmentation
- Registration Number
- NCT05548049
- Lead Sponsor
- Marmara University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Piezosurgery Group Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation In the experimental group, a piezosurgical device was used to harvest the bone block from the ramus area. Conventional Group Bone harvesting from ramus area with conventional burs for autogenous bone augmentation In the experimental group, a conventional burr was used to harvest the bone block from the ramus area.
- Primary Outcome Measures
Name Time Method Osteotomy time Intraoperative The time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch.
- Secondary Outcome Measures
Name Time Method Change in pain 7 days Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable
Operation time Intraoperative 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.
Change in Mouth opening 7 days 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.
Change in Oral Health-related Quality of Life 14 days Evaluated by OHIP-14
Change in facial swelling 7 days 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.
Trial Locations
- Locations (1)
Marmara University School of Dentistry
🇹🇷Istanbul, Turkey