NCT02358304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

7.4 years

First QC Date

January 16, 2015

Last Update Submit

May 20, 2015

Conditions

Central Giant Cell Granuloma

Outcome Measures

Primary Outcomes (1)

  • Relief sign &symptom and clinical features

    5 years

Secondary Outcomes (1)

  • recurrence rate of CGCG

    5 years

Study Arms (2)

a:Patients with aggressive CGCG

ACTIVE COMPARATOR

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

b; Patients with aggressive CGCG

PLACEBO COMPARATOR

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

Interventions

nasal spray calcitoninDRUG

recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin

a:Patients with aggressive CGCG
PlaceboDRUG
b; Patients with aggressive CGCG

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz university of medical sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Granuloma, Giant Cell

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesMouth DiseasesGranulomaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • touba karagah, DMD

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Sorena Fardisi, DMD

    Shiraz University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Shiraz University of Medical Sciences

Study Record Dates

First Submitted

January 16, 2015

First Posted

February 6, 2015

Study Start

September 1, 2007

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations

IR(1)