The effect of Zinc-D-gluconate on bleeding propensity of the periodontium in patients with chronic parodontitis

The effect of Zinc-D-gluconate on bleeding propensity of the periodontium in patients with chronic parodontitis - a randomised, placebo-controlled, double-blind interventional study - ParoZink01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001866-40-DE

Enrollment

Unknown

Registered

2014-10-28

Start date

2014-12-16

Completion date

Unknown

Last updated

2016-09-26

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

Conditions

Chronic paradontitis in adults with at least 16 own teeth

Interventions

Trade Name: Zink Verla OTC 20mg Product Name: Zink Verla OTC 20mg Pharmaceutical Form: Tablet INN or Proposed INN: Zink-D-Gluconat CAS Number: 4468-02-4 Other descriptive name: ZINC GLUCONATE Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication: chronic parodontis (PSI 3 and 4) Age: 25 to 85 years Minimum of gingival bleeding at six different sites Minimum of 16 own teeth without relevant supernatant crowns or restauration edges 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34

Exclusion criteria

Exclusion criteria: Patients requiring acute parodontal or endodontological treatment Patients with heart-, kidney, liver diseases, as well as know diabetics and tumor patients, especially patients treated with anticoagulants Patients with injuries in the mouth cavity Known hypersensitivity against one of the applied IMP or their ingredients or medications with similar chemical structure Patients being treated with antibiotics, anticoagulants or antiphlogistic medication 14 days prior to being enrolled in the study Pregnancy and breast feeding Smoking

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of variation in bleeding propensity of the gingiva between both treatment groups;Secondary Objective: Comparison of variation in probing depth and loss of attachment between both treatment groups;Primary end point(s): Bleeding upon probing and the number of bleeding sites;Timepoint(s) of evaluation of this end point: Day 20 (+3 days if necessary) of treatment	—

Secondary

Measure	Time frame
Secondary end point(s): Probing depth and loss of attachment;Timepoint(s) of evaluation of this end point: Day 21 (+3 days if necessary) of treatment	—

Countries

Germany

Contacts

Public ContactProf. Dr. Christof Doerfer

UKSH, Campus Kiel

doerfer@konspar.uni-kiel.de00494315972780

Outcome results

None listed

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