Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma
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ClinicalTrials.gov Identifier: NCT02358304 |
Recruitment Status :
Completed
First Posted : February 6, 2015
Last Update Posted : May 21, 2015
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Condition or disease | Intervention/treatment | Phase |
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Central Giant Cell Granuloma | Drug: nasal spray calcitonin Drug: Placebo | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Aggressive Central Giant Cell Granuloma |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
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Active Comparator: a:Patients with aggressive CGCG
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.
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Drug: nasal spray calcitonin
recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin |
Placebo Comparator: b; Patients with aggressive CGCG
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
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Drug: Placebo |
- Relief sign &symptom and clinical features [ Time Frame: 5 years ]
- recurrence rate of CGCG [ Time Frame: 5 years ]Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.

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Ages Eligible for Study: | 15 Years to 30 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358304
Iran, Islamic Republic of | |
Shiraz university of medical sciences | |
Shiraz, Fars, Iran, Islamic Republic of |
Principal Investigator: | touba karagah, DMD | Shiraz University of Medical Sciences | |
Principal Investigator: | Sorena Fardisi, DMD | Shiraz University of Medical Sciences |
Responsible Party: | Reza Tabrizi, Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT02358304 |
Other Study ID Numbers: |
1234567 |
First Posted: | February 6, 2015 Key Record Dates |
Last Update Posted: | May 21, 2015 |
Last Verified: | May 2015 |
Granuloma, Giant Cell Granuloma Lymphoproliferative Disorders Lymphatic Diseases Pathologic Processes Jaw Diseases Musculoskeletal Diseases Stomatognathic Diseases Gingival Diseases Periodontal Diseases |
Mouth Diseases Calcitonin Salmon calcitonin Calcitonin Gene-Related Peptide Katacalcin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents Vasodilator Agents |