New treatment of periodontitis by inhibition of lysine decarboxilase enzyme - New therapy of periodontitis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002192-40-HU

Enrollment

Registered

2006-05-29

Start date

2006-07-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: Exacyl drinking solution Product Name: Exacyl drinking solution Pharmaceutical Form: Gastroenteral solution Pharmaceutical form of the placebo: Mouth wash Route of administration of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: between 20-45 years good dentition good oral health non-smoker Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: suffer from stomatological disease caries incipiens lesions in the upper arch pocket probing depth = 4 mm in the upper arch regular medicine taker took antibiotic in the last 3 month thromboembolic disease, convulsion, kidney damage in the anamnase smoker

Design outcomes

Primary

Measure	Time frame
Main Objective: Our aim is determine for scientific reason how the rate of development of gingivitis relate to biofilm lysine decarboxylase enzyme activity.;Secondary Objective: Our secondary aim is to examine how lysine decarboxylase inhibition affect the development of experimental gingivitis.;Primary end point(s): After mouth washing with placebo (1 week), Exacyl drinking solution (1 week) and placebo (1 week) again a bacterial enzyme activity is measured in plaque, saliva, tongue scraping samples and evaluated with the clinical data. The primary end point is the mean plaque index after 7 days of no oral hygiene in the presence and absence of 5% or 10% tranexamic acid mouth rinsing.	—

Measure

Time frame

Main Objective: Our aim is determine for scientific reason how the rate of development of gingivitis relate to biofilm lysine decarboxylase enzyme activity.;Secondary Objective: Our secondary aim is to examine how lysine decarboxylase inhibition affect the development of experimental gingivitis.;Primary end point(s): After mouth washing with placebo (1 week), Exacyl drinking solution (1 week) and placebo (1 week) again a bacterial enzyme activity is measured in plaque, saliva, tongue scraping samples and evaluated with the clinical data. The primary end point is the mean plaque index after 7 days of no oral hygiene in the presence and absence of 5% or 10% tranexamic acid mouth rinsing.

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Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026