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Clinical Trials/NCT05548049
NCT05548049
Completed
Not Applicable

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

Marmara University1 site in 1 country19 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Bone Resorption
Sponsor
Marmara University
Enrollment
19
Locations
1
Primary Endpoint
Osteotomy time
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ferit Bayram

Assistant Professor

Marmara University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Osteotomy time

Time Frame: 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 Outcomes

  • Change in pain(7 days)
  • Operation time(Intraoperative)
  • Change in Mouth opening(7 days)
  • Change in Oral Health-related Quality of Life(14 days)
  • Change in facial swelling(7 days)

Study Sites (1)

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