The evaluation of safety and efficacy of combination therapy of REGROTH and Cytrans Granules for periodontitis.

Not Applicable

• Conditions: Periodontitis; K05.3

• Registration Number: JPRN-jRCTs051190045
• Lead Sponsor: Murakami Shinya

Brief Summary

In this study, the safety (the primary endpoint) and the efficacy (the secondary endpoint) of the periodontal tissue regenerative therapy using the test drug (REGROTH) and the test device (CytransGranules) were evaluated in severe periodontitis patients. Regarding the primary endpoint and secondary endpoint, the above outcome measures were observed. These results indicate the safety and efficacy of periodontal tissue regenerative therapy using the test drug and the test device for severe periodontitis.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-05
• Study Completion: 2020-11-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• 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 marginal periodontitis and judged to require flap surgery judged to require flap operation by the registered dentist.
2. A tooth which has a vertical bone defect with a probing pocket depth of 4mm or more and a depth of 3mm or more at the mesial or distal site.
3. A tooth with keratinized gingiva, which can be judged as an indication for flap operation and the degree 2 or less.

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 who have used bisphosphonate drugs or have osteoporosis
3. Patients with abnormal gingival overgrowth or its history
4. Patients with malignant tumor, precancerous lesions or findings that they are suspected in oral cavity
5. Tooth having other complicated diseases except periodontitis (apical periodontitis, tooth root fracture etc.) that may affect the periodontal tissue healing
6. Teeth that are expected to undergo treatment that will affect the evaluation of safety or efficacy within 36 weeks after surgery
7. Teeth whose restoration etc. interferes with accurate measurement of the clinical attachment level
8. Patients who remain affected by the treatment performed in the oral cavity within the past 3 months.
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 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.
13. Patient with alcohol/drug addiction
14. Uncontrolled diabetes mellitus patients who have had not adequate glycemic control (HbA1c less than 6.5%).
15. Patients who are pregnant, wishing for pregnancy during this clinical study, under pregnant, or breastfeeding.
16. Patients who are considered to be difficult for follow-up visits such as distant place residents
17. Patients who are restricted from observing the requirements of clinical research for social or domestic environments
18. Patients participated in the clinical studies with interventions for other medical devices or medicines within the past 3 months
19. Patients who have participated in this study
20. For other reasons, Patients who are considered inappropriate as subjects for this clinical study or combination therapy of REGROTH and Cytrans granules by clinical research director or registered dentist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events whose causal relationship with combination therapy of REGROTH and Cytrans Granules can not be ruled out

Secondary Outcome Measures

Name	Time	Method
1) Temporal change of increase rate (%) of alveolar bone<br>2) Temporal change of clinical attachment gain (CAL)<br>3) Temporal change of probing pocket depth (PPD)<br>4) Temporal change of bleeding on probing (BOP)<br>5) Temporal change and improvement rate of Gingivitis Index (GI)<br>6) Temporal change and improvement rate of tooth mobility<br>7) Temporal change of plaque index (PI)<br>8) Temporal change of the width of keratinized gingiva<br>9) Temporal change of gingival recession (REC)<br>10) Adverse events<br>11) Trouble