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Low level laser therapy and magnetotherapy as coadjuvant in bisphosphonate related osteonecrosis of the jaws.

Randomized controlled trial of Low level laser therapy and magnetotherapy as coadjuvant in Bisphosphonate related osteonecrosis of the jaws treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-494fyn
Enrollment
Unknown
Registered
2020-04-22
Start date
2019-03-26
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

Bisphosphonate Related Osteonecrosis of the Jaws

Interventions

In the interventions, all patients will be submitted to surgical treatment for resection of osteonecrosis of the jaws, in a hospital environment and under general anesthesia with the following techniq
Sodium Dipyrone - 1g, IV, 6 / 6h
Nubaim® 10 mg, IV, 6 / 6h if necessary. Dexamethasone 10mg, IV, 12 / 12h
Omeprazole 40 mg, IV, daily dose
Ondansentrone - 08 mg, IV, if necessary
Motor and respiratory physiotherapy. Ice packs on the face for 15 minutes every 02 / 02h Pressure control, respiratory rate, 04 / 04h temperature, O2 saturation. Dextro of 08 / 08h. The evaluations wi
Procedure/surgery
Behavioural

Sponsors

Universidade Nove de Julho
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Consent to participate in the study through a Free and Informed Consent Form signed by the patient, female, 60 years of age or older, using oral Alendronate sodium, with weekly doses of 70mg for at least 2 years. continuously for the prevention and or treatment of osteopenia or osteoporosis. Presence of jaw osteonecrosis, in stages 1 or 2, according to the AAOMS classification. Patients who have previously undergone oral cavity surgical procedures, such as dental extractions or implants, performed no more than 6 months prior to the occurrence of osteonecrosis.

Exclusion criteria

Exclusion criteria: Presence of jaw osteonecrosis at stage 0 or 3, according to AAOMS. Presence of spontaneous osteonecrosis in the jaws. Pathological fractures by osteonecrosis. Use of alendronate for less than two years or discontinued. Need to use synthesis material (plate and screws). Indication of the use of alendronate sodium due to malignant neoplasms, bone metastases, Paget's disease or any indication other than osteoporosis or osteopenia. Patients undergoing head and neck radiotherapy in the last 5 years. Patients undergoing hyperbaric chamber sessions in the last 2 years. Patients with blood dyscrasias, renal failure, liver failure, cardio respiratory failure, immune deficiency, malignant neoplasms, AIDS or septicemia.

Design outcomes

Primary

MeasureTime frame
evaluate the response of photobiomodulation and magnetotherapy as adjuvants to the surgical treatment of jaw osteonecrosis induced by the use of sodium alendronate using the Hounsfiel unit gray scale in computed tomography at 0 and 60 days.

Secondary

MeasureTime frame
Observe the healing of the oral mucosa, according to visual clinical examination and photograph in: closed suture, partially closed suture or open suture with dehiscence and bone exposure. ;Determine postoperative pain using the Visual Analog Scale (VAS).;Analyze the inflammatory and infectious process through biochemical analysis through: Complete blood count, PCR, VHS, CPK and DHL before and after surgery, in addition to measuring the local temperature using a digital thermometer

Countries

Brazil

Contacts

Public ContactAndre Rodriguez

Universidade Nove de Julho

andrerodriguez@gmail.com+55 11 985159206

Outcome results

None listed

Source: REBEC (via WHO ICTRP)