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Efficacy of surgical laser during orthognathic surgeries

Efficacy and safety of diode laser during circumvestibular incision for Le Fort I osteotomy during orthognathic surgeries: a triple-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8pbjf5
Enrollment
Unknown
Registered
2017-07-26
Start date
2015-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentofacial deformity

Interventions

Thirty patients will be allocated to one of the 3 groups. Group 1: The circumvestibular incision for Le Fort I osteotomy will be performed using a scalpel blade number 15
Group 2: The circumvestibular incision for Le Fort I osteotomy will be performed with monopolar electrocautery (blend function, power 35W)
Group 3: The circumvestibular incision for Le Fort I osteotomy will be performed with diode surgical laser (Gallium and Aluminum Arsenide, Thera Laser Surgery, São Carlos, São Paulo) with the followin
2) power 2.5W
3) continuous mode by contact
4) 600 ?m optical fiber.
Procedure/surgery

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Hospital da Baleia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Both genders with dentofacial deformities, aged 18 years or older, who have indication of orthognathic surgery

Exclusion criteria

Exclusion criteria: Will be excluded from the study patients using analgesics or anti-inflammatories; syndromic; immunosuppressed; diabetic patients with coagulopathies; uncontrolled hypertensive patients and patients with a history of trauma or previous surgery involving the upper lip. These clinical conditions will be determined through anamnesis and laboratory tests.

Design outcomes

Primary

MeasureTime frame
In each procedure, the mucosa to be incised will be demarcated with methylene blue and the length of the incision measured in millimeters (mm). Two timers will be activated simultaneously at the beginning of the incision. One will be deactivated after the end of the incision (incision time) and the other after the end of the suture (total surgical time). The incision velocity will be calculated in millimeters per second (mm/s), dividing the length of the incision by the incision time (in seconds)

Secondary

MeasureTime frame
Evaluate the safety of the diode laser according to: intraoperative bleeding; functional changes in feeding and speech; postoperative pain; the wound healing; postoperative edema; rates of infections. Transoperative bleeding will be assessed after incisions on a four-point scale. Bleeding absent; Minimal bleeding; Normal bleeding; Bleeding. The incisions will be evaluated weekly to measure the time until complete wound healing. In cases of postoperative infection all data will be recorded. To consider the infection, clinical signs such as fever, myopathy, prostration, cervical lymphadenopathy and drainage of local purulent secretion should be present. According to the hospital protocol, the infection should be confirmed through a complete blood count (leukocytosis) and PCR (C-reactive protein). The visual analogue scale (EVA) will be used to evaluate the functional alterations of feeding and speech at the 1st, 7th, 28th, 60th and 180th days after surgery and to measure the intensity of pain 24h, 48h, 72h and 7 days after the surgery. Regarding the functional alterations, 0 means "no discomfort" and 10 "extreme discomfort". Patients will be instructed to scale the intensity of pain in each period, with 0 meaning "no pain" and 10 "extreme pain".

Countries

Brazil

Contacts

Public ContactFilipe Oliveira

Universidade Federal de Minas Gerais

filipejaeger@gmail.com+55 (31) 99210-2150

Outcome results

None listed

Source: REBEC (via WHO ICTRP)