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Phase 2 N=117 Randomized Prevention

OZONE_EXO: Comparative Analysis of Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study

MEDICATION RELATED OSTEONECROSIS OF THE JAW

Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase — 2; 2.49 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
OxigenOzone_Insufflation (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Palermo
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase
2; 2.49
PRIMARY
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Proliferative Phase:
4.24; 3.7
PRIMARY
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Remodelling Phase
3; 2.96
SECONDARY
Healing Evaluation Using IPR Scale: Total Process
9.37; 9.15

Summary

Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents; it is also a potentially painful and debilitating condition. Today, no specific studies have prospectively evaluated the efficacy of its treatment and no robust standard of care has been established. Among non-invasive procedures to treat MRONJ, the use of medical ozone (O3) arises for its properties and has been deployed and evaluated. O3 has generally proven to play a role in the treatment of chronic, nonhealing, or ischemic wounds, due to its antimicrobial and anti-oxidant properties and to bio-stimulation; it has been extensively used for different medical approaches and purposes. In oral cavity, local applications are carried out by ozonized water (i.e. spray or compress) or gel. The aim of this study was to carry out a case-control study in order to compare two different protocols of dental extractions in patients at risk of MRONJ, with and without infiltration of a mixture of oxygen-ozone. All the cases in our study are cancer and oncologic and osteometabolic patients undergoing high-risk therapy for MRONJ (antiresorptive and antiangiogenic drugs) who require dental extractions with a poor prognosis. During the first examination (T0), medical, pharmacological, and dental history of patients are recorded. Data collected are: (1) age; (2) gender; (3) indications for use, type, cumulative dose and duration of MRONJ-related drugs; (4); history of chemotherapy; (5) other medications; (6) other diseases; (7) smoking. For each patient, an orthopantomography and a cone beam computed tomography of the teeth are performed only if indicated.

Eligibility Criteria

Inclusion Criteria

  • age ≥ 18 yrs
  • patients at risk of developing MRONJ for previous or current administration of drugs related
  • extraction of teeth with a poor prognosis due to severe decay and/or periodontitis

Exclusion Criteria

  • previous radiation in the head and neck area
  • neoplastic involvement of the jaw
  • previous MRONJ diagnosis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06072404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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