Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-20 @ 3:43 PM
Study NCT ID:
NCT02358304
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2015-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma
Sponsor:
Shiraz University of Medical Sciences
Organization:
Study Overview
Official Title:
Treatment of Aggressive Central Giant Cell Granuloma
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: