NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032220261

Registered date:10/08/2022

Clinical outcomes of Guided Bone Regeneration Using Cytrance Granule and Cytrance Elashield

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedTooth Loss/Alveolar Bone Losses
Date of first enrollment25/07/2023
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Guided bone regeneration

Outcome(s)

Primary OutcomeChange in volume of the buccal bone adjacent to implant
Secondary OutcomeSurvival rate of the implant Plaque Index(PI) Probing Pocket Depth(PPD) Sulcus Bleeding Index(SBI) Hight of peri-implant mucosa Histology

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteriaPatients aged 20 years old or more who can acquire written consent by themselves for participation in this study and who meet both of the following conditions will be selected. 1. Patients aged 20 years old or more and below 80. 2. Patients who have been fully informed of the study and who have given written consent of their own free will after full understanding of the study.
Exclude criteriaThe following patients are excluded from this study. 1. Patients with implants which was not able to achieve initial stability. 2. Patients with insufficient periapical bone volume, with an exposed implant area of more than 5 mm. 3. Patients with severe blood disorder or bone target hormone metabolic disorders. 4. Patients who suspected collagenosis and the abnormalities of calcium metabolism organs such as kidney and gastrointestinal tract 5.Patients under dialysis treatment or steroid use. 6. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.9%). 7. Patients with uncontrollable complications that are restricted from observing the requirements of this clinical research, such as severe disease (infection, immunodeficiency, heart disease, etc) or psychiatric disorder. 8. Patients with or with a history of malignant tumors. 9. Patients under anti-resorptive agents medication. 10. Patient with alcohol/drug addiction. 11. Smokers 12. Patients who are restricted from observing the requirements of clinical research for social or domestic environments. 13. Patients who participated in clinical studies with interventions for other medical devices or drugs within the past 3 months. 14. Patients who fall into any of the following categories : pregnant, possibly pregnant, within 28 days postpartum, or lactating. 15. Patients who are considered inappropriate as subjects for this clinical study by the clinical research director or registered dentist for other reasons.

Related Information

Contact

Public contact
Name Masaki Shibasaki
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo Tokyo Japan 113-8510
Telephone +81-3-5803-5773
E-mail shibirm@tmd.ac.jp
Affiliation Tokyo Medical and Dental University
Scientific contact
Name Eriko Marukawa
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo Tokyo Japan 113-8510
Telephone +81-3-5803-5773
E-mail eriko.m.osur@tmd.ac.jp
Affiliation Tokyo Medical and Dental University