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Autogenous Ramus Bone Block Harvesting With Piezosurgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05548049
Enrollment
19
Registered
2022-09-21
Start date
2021-09-01
Completion date
2022-07-01
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Resorption

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.

Interventions

DEVICEBone harvesting from ramus area with piezosurgery for autogenous bone augmentation

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.

DEVICEBone harvesting from ramus area with conventional burs for autogenous bone augmentation

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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Osteotomy timeIntraoperativeThe time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch.

Secondary

MeasureTime frameDescription
Change in facial swelling7 daysWith 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.
Change in pain7 daysPostoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable
Change in Mouth opening7 daysThe 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 Life14 daysEvaluated by OHIP-14
Operation timeIntraoperativeThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026