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Insulin Versus Hyaluronic Acid in Management of Periodontal Defects

Plain-language guide to NCT05746676: phase 3 randomized trial of Insulin (regular human), gum disease (periodontal) & oral health, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05746676
Phase
phase 3
Status
status unknown
Start
2023-01-12
Completion (planned or actual)
2023-08
Participants
30 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Periodontal Diseases; Periodontal Pocket
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Insulin (regular human) for gum disease (periodontal) & oral health.

In this study, insulin and hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically.

It had two arms (groups): group 1 (active comparator) and group 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

N this study, insulin versus hyaluronic acid will be used after open flap debridement in treatment of periodontal defects. outcome will be evaluated clinically and radiographically after a follow up period.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Patients diagnosed with periodontitis.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients with systemic illness that contraindicate periodontal surgery.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the gum disease (periodontal) & oral health participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2023-01-12 with completion listed for 2023-08.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: clinical evaluation (time frame: 6 months). radiographic evaluation (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 30 people with gum disease (periodontal) & oral health.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Gum disease (periodontal) & oral health research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.