Efficacy of Zinc L-Carnosine Mouth Rinse

What Was Tested

In this phase 3 trial, researchers set out to test Carnosine.

A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal tissues and pain after scaling and root planing.

It had three arms (groups): Zinc L-Carnosine mouth rinse (experimental), Chlorhexidine (active comparator) and Water (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

A randomized, double blind, 3 group parallel study with random allocation of 75 patients to any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and placebo (water) control.

Three days after professional oral hygiene, which aimed at the normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI; SI) outcomes of the study are measured to obtain baseline information, and then scaling and root planing are carried out.

The participants will be advised to follow their regular oral hygiene procedures (tooth brushing) in addition to the allocated mouth rinse.

They will be examined again for primary and secondary outcomes at 7 and 21 days.

Who Took Part

75 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients with a PSR score greater than 2 that undergo a session of scaling and root planing.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: use of mouth rinses or local or general medication in the preceding three weeks; any condition related with allergy or sensitivity with the mouth rinses ingredients; systemic and chronic diseases in progress.

How the Study Was Run

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

Because people in this Carnosine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Carnosine 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 Carnosine.

Those kept unaware of assignments: participant and investigator.

It started in 2020-06 with completion listed for 2020-06-22.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Healing Index (H.I.) (time frame: 0, 7, 21 days). Change in the Visual Analogue Scale (VAS) of pain (time frame: 0, 7, 21 days).

It also tracked 4 secondary outcomes, for example Change in Modified Sulcus Bleeding index (Mombelli) (mSBI), Change in Full Mouth Plaque Score (O'Leary) (FMPS), Change in Calculus index (Volpe-Manhold index) (VMI) and Change in Stain index (Macpherson stain index) (S.I.).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Carnosine in 75 people.

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

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