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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.
The purpose of this study was to answers following clinical questions:
1) Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. Hypotheses of this study that ultrasonic bone scalpel can improve BSSO and its postoperative results due to strong cutting efficiency and soft tissue protective effect.
Surgical procedure; After removing the full thickness mucoperiosteal flap lingula was localized. 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. In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur. Groups are selected randomly.
c- Follow up
The predictor variable was the type of instrument used for bone osteotomy. The instruments were ultrasonic bone scalpel and Lindeman bur. The main outcome variable are the cutting time and NSD. All patients were followed for 6 months.The authors used the 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software to evaluate the amount of postoperative edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lindeman | Experimental | BSSO were performed with Lindeman and round bur |
|
| Bone scalpel | Active Comparator | BSSO were performed unilaterally using an ultrasonic bone scalpel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional | Device | In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur (Karl Storz, Tuttlingen, Germany) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The length of the procedure | this is recorded from mucogingival incision to the sagittal splitting in minutes by an unbiased researcher. The reason for determining this period is that the amount of mandibular movement and the degree of fixation difficulty vary, especially in facial asymmetric patients. | during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Emin DemirbaÅŸ, 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selin Çelebi | Kayseri | Melikgazi | 38039 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18022466 | Background | 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. | |
| 20739116 | Background | 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. |
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| ID | Term |
|---|---|
| D019767 | Maxillofacial Abnormalities |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D018640 | Stomatognathic System Abnormalities |
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double blind
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|
| Bone Scalpel | Device | 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 |
|
|
| The splitting time |
this is recorded for the right and left sides to determine the difficulty of splitting, respectively. If the time required to complete the splitting was less than 100 seconds, it was determined as 'easy,' between 100-200 seconds as 'medium'; if more than 200 seconds, it was determined as 'difficult.' |
| during procedure |
| The pattern of the split | this is evaluated by cone-beam computed tomography that is classified into four types according to lingual split scale of Plooij et al | during procedure |
| postoperative edema | The authors used the 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software to evaluate the amount of postoperative edema. Three-dimensional images were taken at maximum intercuspation when the lips were free and the eyes were open. The images were taken at 3 days, and at 6 months after surgery. | up to six months |
| 11988921 | Background | 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. |
| 23182371 | Background | 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. |
| 2056370 | Background | 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. |
| 28595839 | Background | 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. |
| 24742747 | Background | 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. |
| 15263877 | Background | Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian. |
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| 19846184 | Background | 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. |
| 13773910 | Background | 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. |
| 32771031 | Background | 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. |
| 23841662 | Background | 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. |
| 25795191 | Background | 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. |
| 31669455 | Background | 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. |
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| 17356890 | Background | 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. |
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| D009057 | Stomatognathic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |