Central Giant Cell Granuloma Clinical Trial
Official title:
Treatment of Aggressive Central Giant Cell Granuloma
Verified date | May 2015 |
Source | Shiraz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics Committee |
Study type | Interventional |
The main objective of this randomised clinical trial is to is to compare the frequency of recurrence between patients who received nasal spray calcitonin after curettage of Central Giant Cell Granuloma and without it.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 30 Years |
Eligibility |
Inclusion Criteria: - clinical and histopathological diagnosis of aggressive CGCG based on accepted criteria established by chuong etal normal level of calcitonin and serum Parathyroid hormone(PTH) Patients of both sexes between 13 to 30 year's old Patients who gave written informed consent Patients who were willing for evaluation in the fallow up session Primary size of the lesion should be more than 5 cm in CBCT Exclusion Criteria: - Participants demonstrating a systemic disease which affects bone healing,brown tumor ,pregnancy , recently corticosteroid therapy , previous surgical intervention for CGCG or refused study enrollment and whom they could not continue the study for private or social reasons were excluded from the study sample. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Shiraz university of medical sciences | Shiraz | Fars |
Lead Sponsor | Collaborator |
---|---|
Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relief sign &symptom and clinical features | 5 years | Yes | |
Secondary | recurrence rate of CGCG | Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation. | 5 years | Yes |