Vitamin D Status With Early Childhood Caries

What Was Tested

The trial (not phased) is built around Parathyroid Hormone (PTH 1-84).

The aim of Study: To determine if there is a relationship between vitamin D deficiency and the development of Early Childhood Caries (ECC).

It had two arms (groups): caries group (experimental) and free caries group (experimental).

The registry classes the interventions as diagnostic test.

More on the Plan

Methodology: This is a case-control pilot study to determine the relationship of vitamin D deficiency to the prevalence and severity of ECC.

Patient selection and examination following inclusion and exclusion criteria, an Informed consent form will obtain from the parent or guardian after explaining the study in detail.

Patients have a yearly pediatric medicine exam and blood drawn regardless of their participation in the study.

Blood Samples: The operating room (OR) staff obtained blood samples while the patient will be under GA prior to the initiation of dental treatment.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 3 years up to 6 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Cases: Patients diagnosed with ECC who are treatment planned to receive full mouth dental rehabilitation under General Anesthesia (GA). Age 71 months or younger. Controls: patients who present with no frank cavitated lesions upon visual and radiographic examination who are:. Patients of record at SFH for an annual exam with blood work patients will schedule to undergo an otolaryngology procedure under GA.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: patients with an asa classification of 2 or greater; patients received vitamin d supply; controls: patients who present with frank cavitated lesions upon visual and radiographic examination.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Parathyroid Hormone (PTH 1-84) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Parathyroid Hormone (PTH 1-84) group and the comparison group ran side by side rather than switching.

In this single-blind Parathyroid Hormone (PTH 1-84) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-10-30 with completion listed for 2018-02-20.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: vitamin D level of caries and caries free groups (time frame: 7 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Parathyroid Hormone (PTH 1-84) in 60 people.

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

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.