NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071220088

Registered date:16/01/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients receiving high-dose antiresorptive agent
Date of first enrollment16/01/2023
Target sample size128
Countries of recruitment
Study typeInterventional
Intervention(s)Insert of antimicrobial(MINOCYCLINE) penetrated collargen plug(TERUPLUG) for post-extraction tooth socket, close the wound.

Outcome(s)

Primary OutcomeMRONJ onset rate 2 months after tooth extraction in each group
Secondary Outcome1. 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 maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Sakiko Soutome
Address 1-7-1, Sakamoto, Nagasaki-shi Nagasaki Japan 852-8501
Telephone +81-95-819-7698
E-mail sakiko@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name Sakiko Soutome
Address 1-7-1, Sakamoto, Nagasaki-shi Nagasaki Japan 852-8501
Telephone +81-95-819-7698
E-mail sakiko@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital