Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma

Phase 2

Completed

• Conditions: Central Giant Cell Granuloma
• Interventions: Drug: nasal spray calcitonin; Drug: Placebo

• Registration Number: NCT02358304
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

A total of 24 patients with aggressive Central Giant Cell Granuloma (CGCG )will be selected . All examinations were performed by calibrated clinicians and gender, age, medical history, symptoms, lesion size and site, disease duration and form of treatment were recorded for all participant. Radiographic examination with cone beam computed tomography (CBCT) and panoramic radiograph was done for all patients. All patients were randomly assigned to one of two treatment groups; 2 weeks after the biopsies were taken.

The case group (n =12 with) underwent 200 IU/day ones a day for 3 months after the surgeries. conservative curettage surgical procedure was done for them. while placebo was treated by curettage of CGCGs and received a placebo ones a day for 3 months after surgeries.. Patients were followed up by a maxillofacial surgeon who did not participated in surgeries.None of surgeons did not aware about the research before and during the operations.Patients were blinded from the drugs which they received after surgeries.

All patients were follow up for 5 years after operations. Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2015-01-16
• Primary Completion: 2015-02
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-06
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a:Patients with aggressive CGCG	nasal spray calcitonin	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.
b; Patients with aggressive CGCG	Placebo	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

Primary Outcome Measures

Name	Time	Method
Relief sign &symptom and clinical features	5 years

Secondary Outcome Measures

Name	Time	Method
recurrence rate of CGCG	5 years	Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.

Trial Locations

Locations (1)

Shiraz university of medical sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of