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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a:Patients with aggressive CGCG | Active Comparator | 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasal spray calcitonin | Drug | recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relief sign &symptom and clinical features | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate of CGCG | Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| touba karagah, DMD | Shiraz University of Medical Sciences | Principal Investigator |
| Sorena Fardisi, DMD | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz university of medical sciences | Shiraz | Fars | Iran |
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| ID | Term |
|---|---|
| D006101 | Granuloma, Giant Cell |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D005882 | Gingival Diseases |
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| Placebo | Drug |
|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D006099 | Granuloma |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |