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

What Was Tested

This registered phase 2 trial tested Calcitonin.

It had two arms (groups): a:Patients with aggressive CGCG (active comparator) and b; Patients with aggressive CGCG (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

A total of 24 patients with aggressive Central Giant Cell Granuloma (CGCG )will be selected .

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.

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.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 15 years up to 30 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Calcitonin and who got the comparison, which limits bias.

The Calcitonin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Calcitonin.

Those kept unaware of assignments: participant and investigator.

It started in 2007-09 with completion listed for 2015-02.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Relief sign &symptom and clinical features (time frame: 5 years).

It also tracked 1 secondary outcome, for example recurrence rate of CGCG.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Calcitonin in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, all human trials.