Effect of Benzydamine Hydrochloride Mouthrinse on Plaque Accumulation in Periodontally Healthy Female Subjects

NCT07565766 | Completed Phase 4

• 1 other identifier: 05-PA-26-22/13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Induced Gingival Disease; Oral Health

Keywords

Benzydamine Hydrochloride; Randomized Controlled Trial; Dental plaque; Oral hygiene; Anti-inflammatory Agent

Outcome Measures

Primary Outcomes (1)

• 3-day plaque accumulation assessed by Plaque Control Record (PCR)

  Plaque accumulation will be evaluated using the Plaque Control Record (PCR), which assesses the presence or absence of supragingival plaque on six surfaces of each tooth. The results will be expressed as the percentage of plaque-positive surfaces relative to the total number of examined surfaces, providing a quantitative measure of plaque regrowth under conditions of suspended mechanical oral hygiene.

  Baseline (Day 0) and Day 3

Secondary Outcomes (1)

• 3-day gingival inflammation assessed by Bleeding on Probing (BoP)

  Baseline (Day 0) and Day 3

Study Arms (2)

Benzydamine Hydrochloride mouthrinse

EXPERIMENTAL

Experimental arm participants will use the assigned mouthrinse containing benzydamine hydrochloride twice daily, rinsing with 15 mL of solution for a standardized duration according to the manufacturer's instructions.

Drug: Benzydamine hydrochloride mouthrinse

Placebo mouthrinse

PLACEBO COMPARATOR

Placebo mouthwash arm participants will use the assigned placebo mouthrinse, formulated to be identical in color, taste, and packaging to ensure effective allocation concealment. The mouthrinse will be used twice daily, with 15 mL of solution, following a standardized rinsing duration in accordance with the manufacturer's instructions.

Other: Placebo mouthrinse

Interventions

Benzydamine hydrochloride mouthrinse DRUG

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.

Benzydamine Hydrochloride mouthrinse

Placebo mouthrinse OTHER

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.

Placebo mouthrinse

Eligibility Criteria

• Gender Eligibility Details: Female subjects were eligible to participate as the pool of participants (students attending Women's General Gymnasium in Zagreb and the School of Dental Medicine, University of Zagreb) is exclusively and predominantly female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• dentate subjects with at least 24 healthy teeth
• no history of periodontal disease, confirmed by a clinically healthy periodontium, defined as probing pocket depth (PPD) ≤ 3 mm and no interdental clinical attachment loss

You may not qualify if:

• pregnant or lactating females
• using hormonal contraceptives
• reporting systemic diseases or pharmacological treatment that could affect gingival inflammation
• use of antibiotics within 6 months before the study

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)