Ultrasonic Bone Scalpel in BSSO

TC Erciyes University

Status: Completed

Conditions: Maxillofacial Abnormalities

Treatments: Device: Bone Scalpel; Device: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT06273189

2017/558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Lindeman

Experimental group

Description:

BSSO were performed with Lindeman and round bur

Treatment:

Device: Conventional

Bone scalpel

Active Comparator group

Description:

BSSO were performed unilaterally using an ultrasonic bone scalpel

Treatment:

Device: Bone Scalpel