The purpose of this study is to examine the inhibitory effect of an ethanol-free 0,2% chlorhexidine digluconate (CHX) mouthrinse on the bacterial plaque growth after professional tooth cleaning in the absence of domestic oral hygiene in healthy volunteers.
Conditions
Interventions
Product Name: Test Solution 1
Product Code: Test Solution 1
Pharmaceutical Form: Oromucosal solution
Pharmaceutical form of the placebo: Oromucosal solution
Route of administration of the placebo: Oro
Sponsors
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: – healthy volunteers – minimum number of 20 natural teeth in the mouth – age = 20 = 50 years – regular dental care at home – healthy mucosa with the exception of gingivitis simplex or periodontal recessions 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: Exclusion Criteria: – systemic diseases – participation in a clinical trial within the last 30 days or subject has already participated in this clinical study – regular use of drugs interfering with plaque formation or the generation of gingival inflammations (4 weeks before and during recruitment) o antibiotics acting locally in the mouth or systemically o steroidal and non-steroidal antiphlogistics o drugs which influence salivation (e.g. antihistaminics, anticholinergics, drugs against hypertension, psychotropics) – pregnancy or lactation – necessity of antibiotic protection prior to dental treatment interventions – current orthodontic therapy or extended restorations – known hypersensitivity to ingredients of the study medication – all types of known allergies – scheduled surgical intervention or hospitalization within the next 6 weeks – open wounds and ulcers inside the oral cavity – superficial, non-bleeding exfoliation of the oral mucosa or other acute local diseases of the oral mucosa (exception: gingivitis simplex) – GI>2 – present or previous alcoholism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the extent of 4-day plaque regrowth after professional tooth cleaning in the absence of personal oral hygiene according to the criteria of the Quigley-Hein plaque index (QHI) with the modification of Turesky et al. 1972. ;Secondary Objective: Evaluation of the progress of gingival inflammation according to the criteria of the Gingival Index (GI) of Löe and Silness (Löe and Silness 1963). ;Primary end point(s): The difference of effects of ethanol-free CHX mouthrinse solution (= test solution 1) vs. placebo will be analysed by applying a one-sided t-test for dependent samples on the pre-post-differences of QH Index as the primary endpoint. | — |
Countries
Germany
Outcome results
None listed