Autogenous Ramus Bone Block Harvesting With Piezosurgery

NCT05548049 | Completed

• 1 other identifier: MUDHF_FB_002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Resorption

Outcome Measures

Primary Outcomes (1)

• Osteotomy time

  The time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch.

  Intraoperative

Secondary Outcomes (5)

• Change in pain

  7 days

• Change in Mouth opening

  7 days

• Change in Oral Health-related Quality of Life

  14 days

• Operation time

  Intraoperative

• Change in facial swelling

  7 days

Study Arms (2)

Piezosurgery Group

EXPERIMENTAL

In the experimental group, a piezosurgical device was used to harvest the bone block from the ramus area.

Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation

Conventional Group

ACTIVE COMPARATOR

In the experimental group, a conventional burr was used to harvest the bone block from the ramus area.

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

Interventions

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.

Piezosurgery Group

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.

Conventional Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (12)

• Silva FM, Cortez AL, Moreira RW, Mazzonetto R. Complications of intraoral donor site for bone grafting prior to implant placement. Implant Dent. 2006 Dec;15(4):420-6. doi: 10.1097/01.id.0000246225.51298.67.

  PMID: 17172961 BACKGROUND

• Sohn DS, Ahn MR, Lee WH, Yeo DS, Lim SY. Piezoelectric osteotomy for intraoral harvesting of bone blocks. Int J Periodontics Restorative Dent. 2007 Apr;27(2):127-31.

  PMID: 17514884 BACKGROUND

• Robiony M, Polini F, Costa F, Zerman N, Politi M. Ultrasonic bone cutting for surgically assisted rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg. 2007 Mar;36(3):267-9. doi: 10.1016/j.ijom.2006.08.013. Epub 2006 Nov 16.

  PMID: 17112705 BACKGROUND

• Hanser T, Doliveux R. MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial. Int J Oral Maxillofac Implants. 2018 Mar/Apr;33(2):365-372. doi: 10.11607/jomi.4416.

  PMID: 29534125 BACKGROUND

• Sittitavornwong S, Gutta R. Bone graft harvesting from regional sites. Oral Maxillofac Surg Clin North Am. 2010 Aug;22(3):317-30, v-vi. doi: 10.1016/j.coms.2010.04.006.

  PMID: 20713265 BACKGROUND

• Pereira RS, Pavelski MD, Griza GL, Boos FBJD, Hochuli-Vieira E. Prospective evaluation of morbidity in patients who underwent autogenous bone-graft harvesting from the mandibular symphysis and retromolar regions. Clin Implant Dent Relat Res. 2019 Aug;21(4):753-757. doi: 10.1111/cid.12789. Epub 2019 May 16.

  PMID: 31094060 BACKGROUND

• Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.

  PMID: 19885448 BACKGROUND

• 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.

  PMID: 33262880 BACKGROUND

• Nkenke E, Neukam FW. Autogenous bone harvesting and grafting in advanced jaw resorption: morbidity, resorption and implant survival. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S203-17.

  PMID: 24977256 BACKGROUND

• Nielsen HB, Starch-Jensen T. Lateral ridge augmentation in the posterior part of the mandible with an autogenous bone block graft harvested from the ascending mandibular ramus. A 10-year retrospective study. J Stomatol Oral Maxillofac Surg. 2021 Apr;122(2):141-146. doi: 10.1016/j.jormas.2020.05.020. Epub 2020 May 29.

  PMID: 32480048 BACKGROUND

• Nkenke E, Stelzle F. Clinical outcomes of sinus floor augmentation for implant placement using autogenous bone or bone substitutes: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:124-33. doi: 10.1111/j.1600-0501.2009.01776.x.

  PMID: 19663959 BACKGROUND

• Bayram F, Demirci A. A randomized controlled trial comparing conventional and piezosurgery methods in mandibular bone block harvesting from the retromolar region. BMC Oral Health. 2023 Dec 9;23(1):986. doi: 10.1186/s12903-023-03739-9.

  PMID: 38071300 DERIVED

MeSH Terms

Interventions

Piezosurgery

Intervention Hierarchy (Ancestors)

Ultrasonic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available in 1 month and will be available for 2 years

Locations

TU (1)