NCT06273189

Brief Summary

The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

January 18, 2024

Last Update Submit

February 20, 2024

Conditions

Maxillofacial Abnormalities

Keywords

Sagittal split osteotomyultrasonic bone scalpelneurosensory disturbance

Outcome Measures

Primary Outcomes (2)

  • Cutting Time

    Length of cutting time was considered the time from the beginning the sagittal osteotomy to the end of making the vertical osteotomy line. The right and left side recorded separately.

    during procedure

  • neurosensory disturbance

    Neuro sensory disturbance between the mental foramen and lower lip region on each side was evaluated subjectively after the operation day to a week. The examiner was blinded, and do not know which side of the mandible was randomly allocated to the experimental treatment.that was recorded by visual analog scale( VAS)

    up to six months

Secondary Outcomes (4)

  • The length of the procedure

    during procedure

  • The splitting time

    during procedure

  • The pattern of the split

    during procedure

  • postoperative edema

    up to six months

Study Arms (2)

Lindeman

EXPERIMENTAL

BSSO were performed with Lindeman and round bur

Device: Conventional

Bone scalpel

ACTIVE COMPARATOR

BSSO were performed unilaterally using an ultrasonic bone scalpel

Device: Bone Scalpel

Interventions

ConventionalDEVICE

In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur (Karl Storz, Tuttlingen, Germany)

Also known as: Group I
Lindeman
Bone ScalpelDEVICE

In ultrasonic device group, osteotomies one side of the mandible were performed unilaterally using an ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY) with a serrated standard blade

Also known as: Group II
Bone scalpel

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are included with older than 18 years old,
  • normal hemoglobin level, international normalized ratio in the average range,
  • American Society of Anesthesiologists status of ASA I and II.

You may not qualify if:

  • recent use of nonsteroidal anti-inflammatory drugs and opioid derivatives,
  • having preoperative signs of inflammation in the maxillofacial region,
  • presence of excessive bleeding in the previous surgery,
  • and allergy to drugs. All patients have given written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selin Çelebi

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Location

Related Publications (23)

  • Kim SG, Park SS. Incidence of complications and problems related to orthognathic surgery. J Oral Maxillofac Surg. 2007 Dec;65(12):2438-44. doi: 10.1016/j.joms.2007.05.030.

    PMID: 18022466BACKGROUND

  • Yoshioka I, Tanaka T, Khanal A, Habu M, Kito S, Kodama M, Oda M, Wakasugi-Sato N, Matsumoto-Takeda S, Fukai Y, Tokitsu T, Tomikawa M, Seta Y, Tominaga K, Morimoto Y. Relationship between inferior alveolar nerve canal position at mandibular second molar in patients with prognathism and possible occurrence of neurosensory disturbance after sagittal split ramus osteotomy. J Oral Maxillofac Surg. 2010 Dec;68(12):3022-7. doi: 10.1016/j.joms.2009.09.046. Epub 2010 Aug 24.

    PMID: 20739116BACKGROUND

  • Yamamoto R, Nakamura A, Ohno K, Michi KI. Relationship of the mandibular canal to the lateral cortex of the mandibular ramus as a factor in the development of neurosensory disturbance after bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2002 May;60(5):490-5. doi: 10.1053/joms.2002.31843.

    PMID: 11988921BACKGROUND

  • Bruckmoser E, Bulla M, Alacamlioglu Y, Steiner I, Watzke IM. Factors influencing neurosensory disturbance after bilateral sagittal split osteotomy: retrospective analysis after 6 and 12 months. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Apr;115(4):473-82. doi: 10.1016/j.oooo.2012.08.454. Epub 2012 Nov 20.

    PMID: 23182371BACKGROUND

  • Lanigan DT, Hey J, West RA. Hemorrhage following mandibular osteotomies: a report of 21 cases. J Oral Maxillofac Surg. 1991 Jul;49(7):713-24. doi: 10.1016/s0278-2391(10)80235-6.

    PMID: 2056370BACKGROUND

  • Kohnke R, Kolk A, Kluwe L, Ploder O. Piezosurgery for Sagittal Split Osteotomy: Procedure Duration and Postoperative Sensory Perturbation. J Oral Maxillofac Surg. 2017 Sep;75(9):1941-1947. doi: 10.1016/j.joms.2017.05.003. Epub 2017 May 15.

    PMID: 28595839BACKGROUND

  • Spinelli G, Lazzeri D, Conti M, Agostini T, Mannelli G. Comparison of piezosurgery and traditional saw in bimaxillary orthognathic surgery. J Craniomaxillofac Surg. 2014 Oct;42(7):1211-20. doi: 10.1016/j.jcms.2014.02.011. Epub 2014 Mar 20.

    PMID: 24742747BACKGROUND

  • Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.

    PMID: 15263877BACKGROUND

  • Landes CA, Stubinger S, Ballon A, Sader R. Piezoosteotomy in orthognathic surgery versus conventional saw and chisel osteotomy. Oral Maxillofac Surg. 2008 Sep;12(3):139-47. doi: 10.1007/s10006-008-0123-7.

    PMID: 18629552BACKGROUND

  • Beziat JL, Faghahati S, Ferreira S, Babic B, Gleizal A. [Intermaxillary fixation: technique and benefit for piezosurgical sagittal split osteotomy]. Rev Stomatol Chir Maxillofac. 2009 Nov;110(5):273-7. doi: 10.1016/j.stomax.2009.09.003. Epub 2009 Oct 20. French.

    PMID: 19846184BACKGROUND

  • MCFALL TA, YAMANE GM, BURNETT GW. Comparison of the cutting effect on bone of an ultrasonic cutting device and rotary burs. J Oral Surg Anesth Hosp Dent Serv. 1961 May;19:200-9. No abstract available.

    PMID: 13773910BACKGROUND

  • Sun C, Chen G, Fan T, Li W, Guo Z, Qi Q, Zeng Y, Zhong W, Chen Z. Ultrasonic bone scalpel for thoracic spinal decompression: case series and technical note. J Orthop Surg Res. 2020 Aug 8;15(1):309. doi: 10.1186/s13018-020-01838-9.

    PMID: 32771031BACKGROUND

  • Al-Mahfoudh R, Qattan E, Ellenbogen JR, Wilby M, Barrett C, Pigott T. Applications of the ultrasonic bone cutter in spinal surgery--our preliminary experience. Br J Neurosurg. 2014 Jan;28(1):56-60. doi: 10.3109/02688697.2013.812182. Epub 2013 Jul 10.

    PMID: 23841662BACKGROUND

  • Dammous S, Dupont Q, Gilles R. Three-dimensional computed tomographic evaluation of bilateral sagittal split osteotomy lingual fracture line and le fort I pterygomaxillary separation in orthognathic surgery using cadaver heads: ultrasonic osteotome versus conventional saw. J Oral Maxillofac Surg. 2015 Jun;73(6):1169-80. doi: 10.1016/j.joms.2014.12.017. Epub 2014 Dec 23.

    PMID: 25795191BACKGROUND

  • Demirbas AE, Bilge S, Celebi S, Kutuk N, Alkan A. Is Ultrasonic Bone Scalpel Useful in Le Fort I Osteotomy? J Oral Maxillofac Surg. 2020 Jan;78(1):141.e1-141.e10. doi: 10.1016/j.joms.2019.09.021. Epub 2019 Sep 27.

    PMID: 31669455BACKGROUND

  • Plooij JM, Naphausen MT, Maal TJ, Xi T, Rangel FA, Swennnen G, de Koning M, Borstlap WA, Berge SJ. 3D evaluation of the lingual fracture line after a bilateral sagittal split osteotomy of the mandible. Int J Oral Maxillofac Surg. 2009 Dec;38(12):1244-9. doi: 10.1016/j.ijom.2009.07.013. Epub 2009 Aug 26.

    PMID: 19713076BACKGROUND

  • Hunsuck EE. A modified intraoral sagittal splitting technic for correction of mandibular prognathism. J Oral Surg. 1968 Apr;26(4):250-3. No abstract available.

    PMID: 5237786BACKGROUND

  • Gleizal A, Bera JC, Lavandier B, Beziat JL. Piezoelectric osteotomy: a new technique for bone surgery-advantages in craniofacial surgery. Childs Nerv Syst. 2007 May;23(5):509-13. doi: 10.1007/s00381-006-0250-0. Epub 2007 Mar 14.

    PMID: 17356890BACKGROUND

  • Kramer FJ, Ludwig HC, Materna T, Gruber R, Merten HA, Schliephake H. Piezoelectric osteotomies in craniofacial procedures: a series of 15 pediatric patients. Technical note. J Neurosurg. 2006 Jan;104(1 Suppl):68-71. doi: 10.3171/ped.2006.104.1.68.

    PMID: 16509486BACKGROUND

  • Spinelli G, Mannelli G, Zhang YX, Lazzeri D, Spacca B, Genitori L, Raffaini M, Agostini T. Complex craniofacial advancement in paediatric patients: Piezoelectric and traditional technique evaluation. J Craniomaxillofac Surg. 2015 Oct;43(8):1422-7. doi: 10.1016/j.jcms.2015.07.012. Epub 2015 Aug 1.

    PMID: 26302936BACKGROUND

  • Rana M, Gellrich NC, Rana M, Piffko J, Kater W. Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy - a randomized prospective trial. Trials. 2013 Feb 17;14:49. doi: 10.1186/1745-6215-14-49.

    PMID: 23414112BACKGROUND

  • Pagotto LEC, de Santana Santos T, de Vasconcellos SJA, Santos JS, Martins-Filho PRS. Piezoelectric versus conventional techniques for orthognathic surgery: Systematic review and meta-analysis. J Craniomaxillofac Surg. 2017 Oct;45(10):1607-1613. doi: 10.1016/j.jcms.2017.06.011. Epub 2017 Jul 1.

    PMID: 28843403BACKGROUND

  • Schlee M, Steigmann M, Bratu E, Garg AK. Piezosurgery: basics and possibilities. Implant Dent. 2006 Dec;15(4):334-40. doi: 10.1097/01.id.0000247859.86693.ef.

    PMID: 17172949BACKGROUND

MeSH Terms

Conditions

Maxillofacial Abnormalities

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ahmet Emin Demirbaş, PhD,DDS

    Erciyes U

    STUDY DIRECTOR

  • Yusuf Nuri Kaba, PhD,DDS

    Erciyes U

    PRINCIPAL INVESTIGATOR

  • Suheyb Bilge, PhD,DDS

    Erciyes U

    PRINCIPAL INVESTIGATOR

  • Selin Çelebi, PhD,DDS

    Erciyes U

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 22, 2024

Study Start

December 15, 2018

Primary Completion

December 15, 2020

Study Completion

December 15, 2021

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

TU(1)