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.
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 caseof first group (n =12 with) underwent calcitonin 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.
General information
Acronym
CGCG
IRCT registration information
IRCT registration number:IRCT2015011820711N1
Registration date:2015-02-21, 1393/12/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-21, 1393/12/02
Registrant information
Name
Sorena Fardisi
Name of organization / entity
Shiraz Medical Univercity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 5241
Email address
fardisi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical University of Shiraz
Expected recruitment start date
2007-09-06, 1386/06/15
Expected recruitment end date
2009-04-03, 1388/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma
Public title
Treatment of Aggressive Central Giant Cell Granuloma
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02358304
Registration date
2015-01-16, 1393/10/26
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
st zand
City
shiraz
Postal code
Approval date
2007-07-20, 1386/04/29
Ethics committee reference number
91-01-03-5278
Health conditions studied
1
Description of health condition studied
central giant cell granuloma
ICD-10 code
k10.1
ICD-10 code description
Giant cell granuloma, central
Primary outcomes
1
Description
• Relief sign &symptom and clinical features [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Timepoint
5 years
Method of measurement
Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation
Secondary outcomes
1
Description
• recurrence rate of CGCG [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Timepoint
5 years ]
Method of measurement
Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Reza Tabrizi, DMD
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Memarpoor
Street address
Ghasdasht st
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Reza Tabrizi, DMD
Position
Assistant professor
Other areas of specialty/work
Street address
Ghasdasht ST.
City
Sshiraz
Postal code
Phone
+98 71 3631 2313
Fax
Email
tabmed@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Assistant professor of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Reza Tabrizi, DMD
Position
Assistant professor
Other areas of specialty/work
Street address
Ghasrdasht ST.
City
Shiraz
Postal code
Phone
+98 71 3631 2313
Fax
Email
tabmed@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Resident of maxillofacial surgery of Shiraz University of Medical Sciences
Full name of responsible person
Sorena Fardisi DMD
Position
Resident
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
+98 71 3631 2313
Fax
Email
fardisi@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)