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

Treatment of Aggressive Central Giant Cell Granuloma

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.

Study Overview

• Status: Completed
• Conditions: Central Giant Cell Granuloma
• Intervention / Treatment: Drug: Placebo; Drug: nasal spray calcitonin

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • shiraz University of medical sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relief sign &symptom and clinical features	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence rate of CGCG	Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.	5 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: February 5, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Jaw Diseases; Granuloma; Granuloma, Giant Cell; Physiological Effects of Drugs; Vasodilator Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
• Other Study ID Numbers: 1234567