Clinical trial NCT06273189: Ultrasonic Bone Scalpel in BSSO
Official title: Does Ultrasonic Bone Scalpel Improve Surgical Outcomes in SSRO?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Abnormalities
Keywords: Sagittal split osteotomy
ultrasonic bone scalpel
neurosensory disturbance
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cutting Time
timeFrame: during procedure
measure: neurosensory disturbance
timeFrame: up to six months
Secondary outcomes:
measure: The length of the procedure
timeFrame: during procedure
measure: The splitting time
timeFrame: during procedure
measure: The pattern of the split
timeFrame: during procedure
measure: postoperative edema
timeFrame: up to six months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Selin Çelebi
state: Melikgazi
Study officials:
affiliation: Erciyes U
name: Ahmet Emin Demirbaş, PhD,DDS
role: STUDY_DIRECTOR
affiliation: Erciyes U
name: Yusuf Nuri Kaba, PhD,DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Erciyes U
name: Suheyb Bilge, PhD,DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Erciyes U
name: Selin Çelebi, PhD,DDS
role: PRINCIPAL_INVESTIGATOR
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