Autogenous Ramus Bone Block Harvesting With Piezosurgery

Alveolar Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548049
• Other study ID #: MUDHF_FB_002
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Resorption
• Bone Resorption

Intervention

Device:
• Bone 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.
• Bone 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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Nov 16. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in pain	Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable	7 days
Secondary	Change in Mouth opening	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.	7 days
Secondary	Change in Oral Health-related Quality of Life	Evaluated by OHIP-14	14 days
Secondary	Operation time	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.	Intraoperative
Secondary	Change in facial swelling	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.	7 days