patients with gingivitis MedDRA version: 9.1 Level: LLT Classification code 10018292 Term: Gingivitis
Conditions
Interventions
Trade Name: Glycyron
Pharmaceutical Form: Tablet
INN or Proposed INN: Monoammonium Glycyrrhizate
CAS Number: 53956-04-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
onepharm Research & Development GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male and female patients (aged 18 to 40 years) Patients with gingivitis or mild periodontitis Patients who have at least 4 teeth with GI = 1.5 per tooth at baseline Patients with at least 20 teeth excluding the wisdom teeth Patients must have read, understood and signed the informed consent form 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: Patients with systemic diseases Patients chronically taking medication except contraceptives Patients with moderate and severe periodontitis Patients treated (more than 2 days) with antibiotics, steroidal and non-steroidal antiphlogistics less than 4 weeks prior to the baseline examination and/or such a treatment planned for the duration of the trial Patients chronically treated with topical steroids Patients who smoke or have been smoking more than 5 cigarettes a day during the last 6 months Patients with known hypersensitivity or allergy to the test product and its ingredients, especially licorice, or to medications that have a similar chemical structure Patients with hypertension (BP =139/89 mm Hg) Patients with serum potassium values out of normal range (3.8 – 5.2 mmol/l) Patients with serum sodium values out of normal range (136 -152 mmol/l) Patients with clinically relevant signs of edema Patients with known 11ß-HSD deficiency (syndrome of apparent mineralcorticoid excess) Patients who regularly consume glycyrrhizin or licorice containing products (e.g. confectionary, teas, …) Patients who have participated in another clinical study less than 4 weeks prior to the baseline examination Female patients who are pregnant or breast feeding Female patients of childbearing potential except those fulfilling the following criteria: a.Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH >40mlU/ml) b.Post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy) c.Regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device – IUD) d.Sexual abstinence e.Partner who had vasectomy Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study, Patients can be excluded at the principal investigators discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to prove the efficacy of the IMP in the treatment of patients with gingivitis;Secondary Objective: Proof of safety Determination of the proper dosage;Primary end point(s): Difference between the Gingival Index of Visit 4 and the one of Baseline Visit for 4 marker teeth | — |
Countries
Germany
Outcome results
None listed