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Effect of Benzydamine Hydrochloride Mouthrinse on Plaque Accumulation in Periodontally Healthy Female Subjects
Sponsor: University of Zagreb
Summary
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.
Official title: Effect of Benzydamine Hydrochloride During Short-term Restricted Oral Hygiene: a Randomized, Placebo-controlled Trial
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2013-02
Completion Date
2013-05
Last Updated
2026-05-04
Healthy Volunteers
Yes
Interventions
Benzydamine hydrochloride mouthrinse
Participants assigned to the intervention arm will use a mouthrinse containing benzydamine hydrochloride twice daily. A volume of 15 mL will be used per rinse, following a standardized rinsing duration in accordance with the manufacturer's instructions. During the 3-day experimental period, participants will refrain from all mechanical oral hygiene measures to allow assessment of the chemical effects of the mouthrinse on plaque accumulation and gingival inflammation.
Placebo mouthrinse
Participants assigned to the placebo arm will use a mouthrinse without active pharmacological ingredients, formulated to match the test product in color, taste, and packaging to ensure blinding. The mouthrinse will be used twice daily in a volume of 15 mL, following a standardized rinsing duration in accordance with the manufacturer's instructions. Mechanical oral hygiene measures will be suspended throughout the 3-day experimental period.
Locations (1)
School of Dental Medicine, University of Zagreb
Zagreb, Croatia