Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-05-29 @ 12:45 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006101', 'term': 'Granuloma, Giant Cell'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-02-05', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief sign &symptom and clinical features', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'recurrence rate of CGCG', 'timeFrame': '5 years', 'description': 'Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Central Giant Cell Granuloma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nAll patients were follow up for 5 years after operations. Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT02358304', 'briefTitle': 'Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Treatment of Aggressive Central Giant Cell Granuloma', 'orgStudyIdInfo': {'id': '1234567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'a:Patients with aggressive CGCG', 'description': '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.', 'interventionNames': ['Drug: nasal spray calcitonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'b; Patients with aggressive CGCG', 'description': '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', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'nasal spray calcitonin', 'type': 'DRUG', 'description': 'recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin', 'armGroupLabels': ['a:Patients with aggressive CGCG']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['b; Patients with aggressive CGCG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shiraz university of medical sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'touba karagah, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}, {'name': 'Sorena Fardisi, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shiraz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Shiraz University of Medical Sciences', 'investigatorFullName': 'Reza Tabrizi', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}