The PENTO protocol in Medication-Related Osteonecrosis of the Jaw (MRONJ): a single-center phase IIa trial

Conditions

medication-related osteonecrosis of the Jaw

Brief summary

The primary endpoint is healing as defined by an exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA < 5 mm) at 12 months.

Detailed description

Progression of the modified SOMA score over 12 months: The modified SOMA score will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., Progression of nutritional parameters over 12 months: These parameters are weight (in kg), BMI (in kg/m²), albuminemia (g/L) and pre-albuminemia (mg/L). These parameters will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., 12-month change in EBA (dimension): This endpoint will be assessed quantitatively by the D dimension of EBA, defined as the measurement of the major axis of mucosal loss. This parameter will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months. The evolution of EBA corresponds to the relative regression of D defined by (D at x months - D at inclusion)/D at inclusion., All adverse events are collected via questioning and blood pressure measurement at each follow-up visit (at 1-3-6-12 months). Data collected on adverse events will cover their nature, severity (mild, moderate, severe) and causality.

Related papers

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Interventions

DRUGPENTOXIFYLLINE

DRUGTOCOPHEROL (VIT E)

DRUGAMOXICILLIN AND BETA-LACTAMASE INHIBITOR

DRUGCLINDAMYCIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is healing as defined by an exposure bone area (EBA) less than 5 mm at 12 months. It will be expressed as the percentage of patients who achieved healing (EBA < 5 mm) at 12 months.	—

Secondary

Measure	Time frame
Progression of the modified SOMA score over 12 months: The modified SOMA score will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., Progression of nutritional parameters over 12 months: These parameters are weight (in kg), BMI (in kg/m²), albuminemia (g/L) and pre-albuminemia (mg/L). These parameters will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., 12-month change in EBA (dimension): This endpoint will be assessed quantitatively by the D dimension of EBA, defined as the measurement of the major axis of mucosal loss. This parameter will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months. The evolution of EBA corresponds to the relative regression of D defined by (D at x months - D at inclusion)/D at inclusion., All adverse events are collected via questioning and blood pressure measurement at each follow-up visit (at 1-3-6-12 months). Data collected on adverse events will cover the	—

Measure

Time frame

Progression of the modified SOMA score over 12 months: The modified SOMA score will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., Progression of nutritional parameters over 12 months: These parameters are weight (in kg), BMI (in kg/m²), albuminemia (g/L) and pre-albuminemia (mg/L). These parameters will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months., 12-month change in EBA (dimension): This endpoint will be assessed quantitatively by the D dimension of EBA, defined as the measurement of the major axis of mucosal loss. This parameter will be assessed at patient inclusion and at follow-up visits at 1, 3, 6 and 12 months. The evolution of EBA corresponds to the relative regression of D defined by (D at x months - D at inclusion)/D at inclusion., All adverse events are collected via questioning and blood pressure measurement at each follow-up visit (at 1-3-6-12 months). Data collected on adverse events will cover the

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Countries

France

Outcome results

None listed