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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071220088
Enrollment
128
Registered
2023-01-16
Start date
2023-01-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients receiving high-dose antiresorptive agent high-dose antiresorptive agent, osteonecrosis

Interventions

Insert of antimicrobial(MINOCYCLINE) penetrated collargen plug(TERUPLUG) for post-extraction tooth socket, close the wound.

Sponsors

Omori Keisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
MRONJ onset rate 2 months after tooth extraction in each group

Secondary

MeasureTime frame
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)

Contacts

Public ContactKeisuke Omori

Nagasaki University Hospital

k-omori@nagasaki-u.ac.jp+81-95-819-7698

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026