CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Test composition Saliactive® (olive product, betaine and xylitol) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05463484
NCT05463484Phase 3Completed

Effects of a Composition Delivered Via Toothpaste on the Oral Microbiome, pH, Nitrite/Nitrate Ratio, Elastases, and Inflammation in Patients With Oral Dysbiosis: A Controlled, Randomized, Double-blind Study. Part of Stop Dysbiosis Project

Mucosa Innovations, S.L.·interventional·Posted Jul 19, 2022·Updated Jul 8, 2024

In Brief

A Phase 3 clinical trial evaluating Test composition Saliactive® (olive product, betaine and xylitol), Placebo, and 1 other intervention for Oral Dysbiosis. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Dysbiosis is a condition in which the normal function of an ecological net is altered. In dysbiosis a state of inflammation, a loss of hydration, a change in pH, a loss of the barrier function are all allies of key pathogens that initiate invasion and cytokine and pro-inflammatory mediators release that target other tissues and organs resulting in chronic inflammatory conditions. In health there is a cross-talk between the host and the microbiota in order to maintain and promote a state of eubiosis with a local and general health gain. Dysbiosis reversion has not been solved with the use of antibacterials, antiseptics nor antibiotics. Stop dysbiosis project is focussed on different aspects of human dysbiosis such as oral dysbiosis, skin dysbiosis, vaginal dysbiosis and cancer dysbiosis, between others including the current prospective interventional double-blind randomised clinical trial. One of the most common oral dysbiosis is periodontal and mucosa dysbiosis that courses with inflammation of the gingiva (gingivitis). This inflammation induces specific enzymes that in a later stage destroy connective tissue. The current clinical trial analyzes the effect of a composition (Saliactive ®) delivered to the oral cavity via a daily use toothpaste (YOTUEL® microbiome toothpaste) in a group of patients with oral dysbiosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Dysbiosis
CountriesSpain

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJul 19, 2022
Enrollment StartJul 13, 2021
Primary CompletionFeb 28, 2023
Study CompletionJul 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.0 years ago

Interventions

Test composition Saliactive® (olive product, betaine and xylitol)drug

Fluoridated toothpaste with Saliactive®.

Placebodrug

Fluoridated toothpaste without Saliactive®.

Controldrug

Commercial Fluoridated toothpaste for gingivitis with zinc citrate.