Osteonecrosis of the Jaw, Bisphosphonate Induced Clinical Trial
Official title:
Conservative Versus Surgical Treatment for Medication Related Osteonecrosis of the Jaws (MRONJ) Stages I and II, a Quasi-experimental Clinical Trial With Discovery of Salivary Biomarkers
Medication-related osteonecrosis of the jaw (MRONJ) is a serious complication in patients receiving antiresorptive therapies, such as Bisphosphonates and Denosumab. It is defined by the presence of exposed bone or a fistula that probes bone in the jaws for a period greater than 8 weeks in patient with a history of current or past antiresorptive or antiangiogenic treatment, and in the absence of prior radiotherapy or maxillary bone metastases. Depending on the severity of the disease 4 stages are described. On the other hand, although the presence of alterations in the levels of certain biomarkers in saliva has been documented in patients with MRONJ compared to healthy patients, its applicability in clinical practice is still unknown. Until recently, the status quo favored the adoption of a conservative strategy (non-surgical) for the initial management of patients with stage I and II. However, in recent years, this paradigm has been challenged by multiple authors who report better and more predictable outcomes with surgical treatment. Based on the hypothesis that patients with MRONJ stage I and II subjected to initial surgical treatment have better results than those undergoing conservative (non-surgical) treatment, te research group has designed a unicentric, quasi-experimental clinical trial where the clinical and radiological outcome at the third month of 2 groups of patients with stages I and II MRONJ undergoing non-surgical treatment (Group 1 / control) versus initial surgical treatment (Group 2 / intervention) will be compared. Also, the investigators hypothesize that the patients with complete resolution of the disease will also normalize salivary biomarkers levels unlike those with stable or progressive disease, meaning there is a correlation between clinical and biochemical response. Accordingly, the levels of specific salivary biomarkers at baseline and at the third month will be determined and compared with the clinical outcome. After enrollment patients will be instructed and offered both treatment strategies, and assigned to the corresponding group according to their choice. Patients in group 1 (non-surgical) will receive traditional conservative treatment while patients undergoing surgical treatment will receive the same guidelines of conservative treatment plus surgery according to a specific surgical protocol.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 15, 2024 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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Spain | Hospital Universitario Son Espases | Palma de Mallorca | Baleares |
Lead Sponsor | Collaborator |
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Fundació d'investigació Sanitària de les Illes Balears |
Spain,
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
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Primary | Complete clinical resolution | This is the first of the three possible clinical outcome. The patient has achieved complete mucosal healing meaning there is no signs of bone exposure or fistula, the patient is asymptomatic and thus, can be considered cured. | Third month | |
Primary | Clinically stable disease | Second possible clinical outcome. The patient has not been cured but has neither gotten worse meaning that the area of bone exposure (in square centimeters) is equal or not greater than 50 percent of the initial measurement, and has not developed disease up-staging. | Third month | |
Primary | Clinical progression or up-staging | Third possible clinical outcome. The patient has gotten worse meaning that the area of bone exposure (in square centimeters) is greater than 50 percent of the initial measurement, or the patient has progressed to a higher stage. | Third month | |
Primary | Level of salivary NTX | Expressed in nanomoles of bone collagen equivalents | Third Month | |
Primary | Level of salivary MMP-9 | Expressed in nanograms/milliliters | Third Month | |
Primary | Levels of IL-1a, IL-1b, IL-6, IL-17 and IL-36a. | Expressed in picograms/milliliters | Third Month | |
Secondary | Radiological absence of radiolucent areas or complete ossification. | This is the first of three possible radiological outcomes and means that the patient has no longer radiological signs of necrotic bone (sequestrum or osteolysis) in the CT or CB-CT scan. | Third month | |
Secondary | Radiologically stable disease | Second possible radiological outcome. The radiolucent lesion or sequestrum (measured in centimeters by the greater diameter in the CT or CB-CT scan) is equal or not greater than 50 percent of the initial measurement, and does not meet radiological up-staging criteria. | Third Month | |
Secondary | Radiological progression | Third possible radiological outcome. The radiolucent lesion or sequestrum (measured in centimeters by the greater diameter in the CT or CB-CT scan) is greater than 50 percent of the initial measurement, or meets radiological up-staging criteria. | Third month |