Table 2.

Criteria for excluding subjects.

Exclusion criteria
1. Persons who have a complicated malignant tumor or have its history
2. Persons who have used bisphosphonate drugs or have osteoporosis
3. Persons with abnormal gingival overgrowth or its history
4. Persons with malignant tumor, precancerous lesions, or findings that they are suspected in the oral cavity
5. Persons with severe blood disorder or bone target hormone metabolic disorders
6. Persons suspected of collagenosis and the abnormalities of calcium metabolism organs such as kidney and gastrointestinal tract
7. Persons under dialysis treatment or steroid use
8. Persons with uncontrollable complications who are restricted from observing the protocol of this clinical trial, such as severe disease (infection, immunodeficiency, and heart disease) or psychiatric disorder
9. Persons with alcohol/drug addiction
10. Patients with uncontrolled diabetes mellitus who do not have adequate glycemic control (HbA1c < 6.5%)
11. Persons who are pregnant, wishing to get pregnant during this clinical study, may be pregnant, or breastfeeding
12. Persons who are considered difficult for follow-up visits such as residents staying in remote places
13. Persons who are restricted from observing the protocol of this clinical trial for social or domestic environments
14. Persons who participated in clinical studies with interventions for other medical devices or medicines within the past 3 months
15. Persons who remained affected by the treatment performed in the oral cavity within the past 3 months
16. For other reasons; persons who are considered inappropriate as subjects for this clinical study or combination therapy of REGROTH® and Cytrans® Granules by the clinical research director or registered dentist