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

Not Applicable

Recruiting

• Conditions: Tooth Loss/Alveolar Bone Losses; Alveolar Bone Losses; D016388 D016301

• Registration Number: JPRN-jRCTs032220261
• Lead Sponsor: Marukawa Eriko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients 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.

Exclusion Criteria

The 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in volume of the buccal bone adjacent to implant

Secondary Outcome Measures

Name	Time	Method
Survival rate of the implant<br>Plaque Index(PI)<br>Probing Pocket Depth(PPD)<br>Sulcus Bleeding Index(SBI)<br>Hight of peri-implant mucosa<br>Histology