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Completed

NCT Number: NCT06273189

Ultrasonic Bone Scalpel in BSSO

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.

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Key information

Conditions

Maxillofacial Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selin Çelebi

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional

Device

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

Other names: Group I

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

Other names: Group II

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. The length of the procedure

    Time frame: during 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.

  2. The splitting time

    Time frame: during procedure

    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.'

  3. The pattern of the split

    Time frame: during procedure

    this is evaluated by cone-beam computed tomography that is classified into four types according to lingual split scale of Plooij et al

  4. postoperative edema

    Time frame: up to six months

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Does Ultrasonic Bone Scalpel Improve Surgical Outcomes in SSRO?

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 22, 2024
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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