Central Giant Cell Granuloma Clinical Trial
Official title:
Treatment of Aggressive Central Giant Cell Granuloma
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment