Maxillofacial AbnormalitiesNCT06273189
Ultrasonic Bone Scalpel in BSSO
A study testing Conventional and Bone Scalpel in people with Maxillofacial Abnormalities, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Abnormalities
- What is being tested?
- Conventional and Bone Scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2018to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria are neuropathic disease,
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Ultrasonic Bone Scalpel Improve Surgical Outcomes in SSRO?
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.
Read the detailed description
The purpose of this study was to answers following clinical questions:
- 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.
- Conditions
- Maxillofacial Abnormalities
- Being tested
- Conventional, Bone Scalpel
- Keywords
- Sagittal split osteotomy, ultrasonic bone scalpel, neurosensory disturbance
- Medical subject headings
- Maxillofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalDevice
Also called Group I
In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur (Karl Storz, Tuttlingen, Germany)
Bone ScalpelDevice
Also called Group II
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
| Study group | Role | What they receive |
|---|---|---|
| Lindeman | Experimental | BSSO were performed with Lindeman and round bur Receives: Device: Conventional |
| Bone scalpel | Active comparator | BSSO were performed unilaterally using an ultrasonic bone scalpel Receives: Device: Bone Scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: up to six months
Secondary outcomes (4)
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.
Measured: during procedure
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.'
Measured: 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
Measured: 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.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Dec 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Celebi, TC Erciyes University
- Investigators
- Ahmet Emin Demirbaş, PhD,DDS, Study director, Erciyes UYusuf Nuri Kaba, PhD,DDS, Principal investigator, Erciyes USuheyb Bilge, PhD,DDS, Principal investigator, Erciyes USelin Çelebi, PhD,DDS, Principal investigator, Erciyes U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273189
- Sponsor's protocol ID
- 2017/558
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18022466Yoshioka 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.
PubMed 20739116Yamamoto 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.
PubMed 11988921Bruckmoser 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.
PubMed 23182371Lanigan 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.
PubMed 2056370Kohnke 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.
PubMed 28595839Spinelli 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.
PubMed 24742747Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.
PubMed 15263877Landes 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.
PubMed 18629552Beziat 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.
PubMed 19846184MCFALL 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.
PubMed 13773910Sun 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.
PubMed 32771031Al-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.
PubMed 23841662Dammous 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.
PubMed 25795191Demirbas 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.
PubMed 31669455
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasonic Bone Scalpel Improve Surgical Outcomes in SSRO?
- ClinicalTrials.gov ID
- NCT06273189
- Acronym / sponsor ID
- 2017/558
- Conditions
- Maxillofacial Abnormalities
- Keywords
- Sagittal split osteotomy, ultrasonic bone scalpel, neurosensory disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study was to answers following clinical questions:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind
| Arm | Type | Receives |
|---|---|---|
| Lindeman | Experimental | Device: ConventionalBSSO were performed with Lindeman and round bur |
| Bone scalpel | Active comparator | Device: Bone ScalpelBSSO were performed unilaterally using an ultrasonic bone scalpel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- The exclusion criteria are neuropathic disease,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConventionalAlso: Group IIn conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur (Karl Storz, Tuttlingen, Germany) | Device | Lindeman |
| Bone ScalpelAlso: Group IIIn 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 | Device | Bone scalpel |
Primary outcome
Cutting Time
Time frame: during procedure
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.
neurosensory disturbance
Time frame: up to six months
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)
4 secondary outcomes
The length of the procedure
Time frame: during procedure
The splitting time
Time frame: during procedure
The pattern of the split
Time frame: during procedure
postoperative edema
Time frame: up to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Background: PubMed 18022466Kim 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.
- Background: PubMed 20739116Yoshioka 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.
- Background: PubMed 11988921Yamamoto 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.
- Background: PubMed 23182371Bruckmoser 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.
- Background: PubMed 2056370Lanigan 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.
- Background: PubMed 28595839Kohnke 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.
- Background: PubMed 24742747Spinelli 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.
- Background: PubMed 15263877Vercellotti T. Technological characteristics and clinical indications of piezoelectric bone surgery. Minerva Stomatol. 2004 May;53(5):207-14. English, Italian.
- Background: PubMed 18629552Landes 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.
- Background: PubMed 19846184Beziat 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.
- Background: PubMed 13773910MCFALL 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.
- Background: PubMed 32771031Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Emin Demirbaş, PhD,DDS study director
Erciyes U
Yusuf Nuri Kaba, PhD,DDS principal investigator
Erciyes U
Suheyb Bilge, PhD,DDS principal investigator
Erciyes U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional and Bone Scalpel in people with Maxillofacial Abnormalities, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutting Time (time frame: during procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273189, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.