Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma

• ClinicalTrials.gov Identifier: NCT02358304
• Recruitment Status: Completed
• First Posted: February 6, 2015
• Last Update Posted: May 21, 2015
• Sponsor: Shiraz University of Medical Sciences
• Information provided by (Responsible Party): Reza Tabrizi, Shiraz University of Medical Sciences

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Iran, Islamic Republic of

Shiraz university of medical sciences

Shiraz, Fars, Iran, Islamic Republic of

Sponsors and Collaborators

Shiraz University of Medical Sciences

Investigators

• Principal Investigator: touba karagah, DMD; Shiraz University of Medical Sciences
• Principal Investigator: Sorena Fardisi, DMD; Shiraz University of Medical Sciences

More Information

• 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
• Last Update Posted: May 21, 2015
• Last Verified: May 2015

Additional relevant MeSH terms:

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