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Trial record 27 of 231 for:    CALCITONIN SALMON

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
Sponsor:
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Central Giant Cell Granuloma Drug: nasal spray calcitonin Drug: Placebo Phase 2

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.


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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

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Arm Intervention/treatment
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.
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
Drug: Placebo



Primary Outcome Measures :
  1. Relief sign &symptom and clinical features [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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
Criteria

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.

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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


Locations
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Iran, Islamic Republic of
Shiraz university of medical sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Principal Investigator: touba karagah, DMD Shiraz University of Medical Sciences
Principal Investigator: Sorena Fardisi, DMD Shiraz University of Medical Sciences

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Responsible Party: Reza Tabrizi, Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02358304     History of Changes
Other Study ID Numbers: 1234567
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Granuloma, Giant Cell
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents