Clinical outcomes of Guided tissue regeneration using Cytrance Granule and Cytrance Elashield

Not Applicable

Recruiting

• Conditions: Periodontitis; intrabony defect, furcation involvement; D010518

• Registration Number: JPRN-jRCTs032210705
• Lead Sponsor: Iwata Takanori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Patients aged 20 years old or more who can acquire written consent by themselves for participation in this study and who have teeth that meet all of the following conditions will be selected.
1. A tooth diagnosed as periodontitis and diagnosed to require flap surgery by the registered dentist.
2. A tooth which has a intrabony defect with a probing pocket depth of 6 mm or more and a depth of 3mm or more in the dental X-ray image.
3. A tooth with class 2 furcation involvement in madible.

Exclusion Criteria

The following patients and teeth are excluded from this study.
1. Patients who are complicated malignant tumor or have its history
2. Patients with malignant tumor, precancerous lesions or findings that they are suspected in oral cavity
3. Patients with abnormal gingival overgrowth or its history
4. Tooth having other complicated diseases except periodontitis (apical periodontitis, tooth root fracture etc.) that may affect the periodontal tissue healing
5. Teeth that are expected to undergo treatment that will affect the evaluation of safety or efficacy within 24 weeks after surgery
6. Teeth whose restoration etc. interferes with accurate measurement of the clinical attachment level
7. Patients who remain affected by the treatment performed in the oral cavity within the past 3 months.
8. Patients who have used bisphosphonate drugs or have osteoporosis
9. Patients with severe blood disorder or bone target hormone metabolic disorders
10. Patients who suspected collagenosis and the abnormalities of calcium metabolism organs such as kidney and gastrointestinal tract
11. Patients under dialysis treatment or steroid use
12. Patients with hepatic impairment or whose liver function is considered abnormal.
13. 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.
14. Patients undergoing or previously undergoing radiotherapy
15. Patients with hypertension and hypotension not adequately controlled
16. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.5%).
17. Patients with asthmatics without adequate control.
18. Patients with rheumatic fever
19. Patients with hyperthyroidism
20. Patients who are pregnant, wishing for pregnancy during this clinical study, under pregnant, or breastfeeding.
21.Patients with allergic tendencies and a history of hypersensitivity or allergy to materials containing L-lactide-caprolactone copolymers.
22.Patient who has smoking habit of 11 cigarettes/day or more.
23.Patient with alcohol/drug addiction
24.Patients who are considered to be difficult for follow-up visits such as distant place residents
25. Patients who are restricted from observing the requirements of clinical research for social or domestic environments
26.Patients participated in the clinical studies with interventions for other medical devices or medicines within the past 3 months
27.Patients who have participated in this study
28.For other reasons, Patients who are considered inappropriate as subjects for this clinical study or combination therapy of Cytrans granules and Cytrans elashields by clinical research director or registered dentist.

Study & Design

• Study Type: Observational
• Study Design: Not specified