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IRCT2015011820711N1 IRCT 2015-02-21 Shiraz University of Medical Sciences Treatment of Aggressive Central Giant Cell Granuloma CGCG Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma 2007-09-06 anticipated 24 Complete https://irct.ir/trial/18308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 central giant cell granuloma. Intervention 1: Active Comparator: a:Patients with aggressive CGCG Patients had been clinically with CGCG and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, size, and site of the lesions , duration of disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received nasal spray calcitonin 200 IU/ day for 3 months after surgical curettage was done. Intervention 2: Placebo Comparator: b; Patients with aggressive CGCG Patients had been clinically with CGCG and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, size, and site of the lesions , duration of disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups . second group received placebo after surgical curettage for 3 months.
public Reza Tabrizi, DMD
Ghasdasht ST.
Sshiraz Iran (Islamic Republic of) +98 71 3631 2313 tabmed@gmail.com Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences scientific Reza Tabrizi, DMD
Ghasrdasht ST.
Shiraz Iran (Islamic Republic of) +98 71 3631 2313 tabmed@gmail.com Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences Iran (Islamic Republic of) 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. 15 years 30 years Both k10.1 Giant cell granuloma, central Treatment - Drugs Placebo Active Comparator: a:Patients with aggressive CGCG Patients had been clinically with CGCG and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, size, and site of the lesions , duration of disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups .First group received nasal spray calcitonin 200 IU/ day for 3 months after surgical curettage was done. Placebo Comparator: b; Patients with aggressive CGCG Patients had been clinically with CGCG and confirmed by histopathological findings were selected for the study. Gender, age, medical history, symptoms, size, and site of the lesions , duration of disease were recorded. Local ethical committee approval was obtained before the trial started and all patients gave written informed consent. Patients were randomly divided into two groups . second group received placebo after surgical curettage for 3 months • Relief sign &symptom and clinical features [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]. Timepoint: 5 years. Method of measurement: Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation. • recurrence rate of CGCG [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]. Timepoint: 5 years ]. Method of measurement: Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation. NCT02358304 ClinicalTrials.gov Shiraz University of Medical Sciences Approved 2007-07-20 Shiraz University of Medical Sciences st zand shiraz Iran (Islamic Republic of)