Multi-institutional study on prevention of medication-related osteonecrosis of the jaw after tooth extraction by topical administration of atelocollagen and antibiotics

JRCT ID: jRCTs071220088

Registered date:16/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients receiving high-dose antiresorptive agent
• Date of first enrollment: 16/01/2023
• Target sample size: 128
• Study type: Interventional
• Intervention(s): Insert of antimicrobial(MINOCYCLINE) penetrated collargen plug(TERUPLUG) for post-extraction tooth socket, close the wound.

Outcome(s)

• Primary Outcome: MRONJ onset rate 2 months after tooth extraction in each group

Secondary Outcome

1. quantification of total bacterial count by real-time PCR method
2. adverse events related to study drugs and medical devices (hypersensitivity symptoms, inflammatory changes such as redness and swelling of the oral mucosa)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients receiving ZOMETA or RANMARK therapy who are planned to undergo tooth extraction
2. Patients who received sufficient explanation in participating in this study, and obtained written consent by the patient's free will after sufficient understanding.

Exclude criteria

1. Patients with a history of hypersensitivity to tetracycline antibiotics or animal proteins in the past
2. Patients receiving walfarin potassium, sulfonylurea hypoglycemic agents, methotrexate, porphymer sodium, digoxin, luteal / follicular hormone combination drug, oral contraceptives, vitamin A preparations and retinoid preparations excluding external preparations
3. Other patients who are judged by the principal investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Soutome Sakiko
• Source(s) of Monetary Support: Olympus Terumo Biomaterials Corporation