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Autogenous Ramus Bone Block Harvesting With Piezosurgery

Primary Purpose

Alveolar Bone Resorption

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation

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

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Marmara University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piezosurgery Group

Conventional Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Change in Oral Health-related Quality of Life

Evaluated by OHIP-14

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.

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.

Full Information

NCT ID

NCT05548049

First Posted

September 14, 2022

Last Updated

September 17, 2022

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT05548049

Brief Title

Autogenous Ramus Bone Block Harvesting With Piezosurgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Resorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Piezosurgery Group

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Osteotomy time

Description

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

Time Frame

Intraoperative

Secondary Outcome Measure Information:

Title

Change in pain

Description

Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable

Time Frame

7 days

Title

Change in Mouth opening

Description

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.

Time Frame

7 days

Title

Change in Oral Health-related Quality of Life

Description

Evaluated by OHIP-14

Time Frame

14 days

Title

Operation time

Description

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.

Time Frame

Intraoperative

Title

Change in facial swelling

Description

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Marmara University School of Dentistry

City

Istanbul

ZIP/Postal Code

34854

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

Data will become available in 1 month and will be available for 2 years

Citations:

PubMed Identifier

17172961

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. doi: 10.1097/01.id.0000246225.51298.67.

Results Reference

background

PubMed Identifier

17514884

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.

Results Reference

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PubMed Identifier

17112705

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. doi: 10.1016/j.ijom.2006.08.013. Epub 2006 Nov 16.

Results Reference

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PubMed Identifier

29534125

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.

Results Reference

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PubMed Identifier

20713265

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.

Results Reference

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PubMed Identifier

31094060

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.

Results Reference

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PubMed Identifier

19885448

Citation

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

Results Reference

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PubMed Identifier

33262880

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.

Results Reference

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PubMed Identifier

24977256

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.

Results Reference

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PubMed Identifier

32480048

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.

Results Reference

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PubMed Identifier

19663959

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.

Results Reference

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Autogenous Ramus Bone Block Harvesting With Piezosurgery

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