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Completed

NCT Number: NCT05548049

Autogenous Ramus Bone Block Harvesting With Piezosurgery

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.

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Key information

Conditions

Alveolar Bone Resorption

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation

Device

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.

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

Device

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.

Primary outcomes

  1. 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

  1. Change in pain

    Time frame: 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

  2. Change in Mouth opening

    Time frame: 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.

  3. Change in Oral Health-related Quality of Life

    Time frame: 14 days

    Evaluated by OHIP-14

  4. Operation time

    Time frame: 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.

  5. Change in facial swelling

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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