NIPH Clinical Trials Search

The effect of carbonate apatite grafting to the alveolar cleft on permanent tooth eruption in cleft lip and palate patients.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	cleft lip and alveolus, cleft lip and cleft palate
Date of first enrollment	12/05/2025
Target sample size	5
Countries of recruitment
Study type	Interventional
Intervention(s)	Fill the cleft alveolus with the required amount of test equipment at the time of cleft alveolus surgery

Outcome(s)

Primary Outcome	Eruption of permanent teeth
Secondary Outcome	Bone bridging, CT values, volume of the defect, distance in height cross section, surface area Perioperative stress assessment (autonomic activity, blood pressure, heart rate, VAS, analgesic usage)

Key inclusion & exclusion criteria

Age minimum	>= 7age old
Age maximum	<= 11age old
Gender	Both
Include criteria	(1) Diagnosis: cleft lip and alveolus, cleft lip and palate (2)Disease stage, stage of disease: Cases in which the dentist determines that cleft lip and palate iliac bone grafting is necessary (3) Age, sex 7-11 years old, male and female (4) Inpatients, outpatients (5) Period of treatment: Hospitalization period and until the eruption of the intended permanent teeth after discharge from the hospital.
Exclude criteria	1. Patients with abnormal bone-targeting hormone metabolism 2. Patients with abnormalities in calcium metabolism in the kidney, digestive organs, etc. 3. Patients with osteoporosis or bone metabolism disease, or patients who are being or have been treated with bisphosphonates. 4. Patients with a history of hypersensitivity to drugs, foods, accessories, or chemicals. 5. Patients on dialysis 6. Patients with hematological diseases Patients with suspected collagen disease 8. Patients receiving steroids or immunosuppressive drugs (excluding topical administration) 9. Patients with diabetes mellitus that has not been treated or has not improved with medication (not medically controlled) 10. Patients with fever or other infectious complications 11. Patients with immunodeficiency 12. Patients with serious complications (cardiac disease, etc.) 13. Patients undergoing or previously undergoing radiotherapy 14. Patients with hepatic impairment or abnormal liver function tests 15. Patients with hypertension or hypotension 16. Patients with rheumatic fever 17. Patients with hyperthyroidism (Exclusion criteria in terms of risk/benefit balance) 18. patients with concomitant diseases affecting the autonomic nervous system 19. patients with concomitant malignancy or with a history of malignancy within 5 years 20. other patients who are judged by the physician to be ineligible for the treatment