NCT02358304

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

Treatment of Aggressive Central Giant Cell Granuloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Giant Cell Granuloma

Interventions

Type	Name	Description
DRUG	nasal spray calcitonin	recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin
DRUG	Placebo

Timeline

• Start date: 2007-09-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2015-02-06
• Last updated: 2015-05-21

Locations

1 site across 1 country: Iran