Initial Management of MRONJ Stages I and II, a Clinical Trial With Detection of Salivary Biomarkers
Osteonecrosis of the Jaw, Bisphosphonate Induced, Osteonecrosis of the Jaw, Bisphosphonate Related
About this trial
This is an interventional treatment trial for Osteonecrosis of the Jaw, Bisphosphonate Induced focused on measuring Mronj, Dronj, Biomarkers, Saliva, Surgical treatment, Bronj
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of stage I or stage II medication related osteonecrosis of the jaws (MRONJ) according to the 2014 AAOMS position paper.
Exclusion Criteria:
- Coexistence of any medical or social condition that prevents proper adherence to treatment or follow-ups (dependent patients without adequate socio-familiar support, drug addiction, severe psychiatric illness, terminal disease with life expectancy less than 3 months).
- Coexistence of Brown's Tumor, Paget's Disease or other bone diseases with the exception of Osteoporosis or bone metastases.
Sites / Locations
- Hospital Universitario Son EspasesRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Group 1 (non-surgical treatment)
Group 2 (surgical treatment)
Soft diet. Suspension of the use of prostheses or intraoral devices. Oral hygiene guidelines. Topical antiseptics: in the form of mouthrinses with 0.12% chlorhexidine after every meal and clorhexidine gel over the exposed bone or fistula. Systemic antibiotics: for patients in stage 2 in which active acute infection is detected with Amoxicillin/Clavulanic Acid 875/125 mg every 8 hours for 2 weeks. Those allergic to penicillin will receive clindamycin 300 mg every 8 hours for 2 weeks or Levofloxacin 500 mg / day for 2 weeks. Systemic antibiotic treatment can be prolonged indefinitely until infection and symptoms are controlled.
Same guidelines of conservative treatment plus surgical treatment according to the following protocol: Specific protocol for surgical treatment: Wide mucoperiosteal flaps and complete surgical excision of necrotic bone together with a mucosa margin of at least 2 mm. Removal of dental pieces included in the diseased area and regularization of bony margins avoiding leaving sharp edges or spicules. Secure a two layered waterproof closure without tension (simple or with local flaps). Samples will be sent for Pathological and microbiological analysis. Stitches removal after two weeks Postoperative systemic antibiotic following the mentioned protocol until stitches removal.