Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash

University of Barcelona24 enrolled

Overview

This study evaluates the antiplaque efficacy of a bioflavonoid-based mouthwash compared to a positive control (0.12% chlorhexidine mouthwash). Following a baseline oral health assessment, participants will use the assigned mouthwash twice daily for 4 consecutive days while refraining from all mechanical oral hygiene practices (e.g., tooth brushing). The trial follows a 2-phase crossover design, where participants use one mouthwash in the first phase and the other in the second phase, separated by a 15-day washout period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gingival Inflammation Dental Plaque Accumulation

Interventions

Bioflavonoid mouthwashDRUG

Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.

Chlorhexidine 0.12% mouthwashDRUG

Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with \> 20 teeth present, with a minimum of 5 teeth per quadrant. * Individuals \>18 years of age Exclusion Criteria: * Individuals with systemic diseases (ASA III o IV). * Individuals with systemic diseases or undergoing pharmacological treatment that may modify gingival health. * Individuals with periodontal disease (probing depth \> 5mm and/or clinical attachment loss \>2mm). * Individuals currently under orthodontic treatment. * Individuals with removable dental prostheses. * Individuals with known allergies to any ingredient in the study mouthwashes. * Individuals presenting with oral mucosal lesions. * Individuals who have used antibiotics, antifungals, corticosteroids, or contraceptives within 3 months prior to the study. * Individuals who have used chlorhexidine mouthwash or any other oral antiseptic within 15 days prior to the start of the study. * Individuals with any active carious lesions or any cervical restorations present on any tooth.

Locations (1)

Hospital Odontològic Universitat de Barcelona

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

Total plaque accumulation

Plaque levels were recorded using the Turesky modification of the Quigley and Hein plaque index (TQHPI). Scores range from 0 to 5, where 0 = no plaque and 5 = plaque covering two-thirds or more of the crown surface. Higher scores indicate greater plaque accumulation.

Time frame: Day 4 of Phase 1 and Day 4 of Phase 2

Gingival Inflammation Score

Gingival inflammation was evaluated on the buccal and lingual surfaces using the Loe Gingival Index via gentle probing. Scoring criteria was defined as: 0= normal gingiva, 1= mild inflammation- slight change in color, oedema no bleeding on probing, 2= moderate inflammation- redness, oedema, bleeding on probing, 3= severe inflammation- marked redness, oedema, ulceration, tendency to spontaneous bleeding.

Time frame: Day 1 and Day 4 of Phase 1; Day 1 and Day 4 of Phase 2

Secondary Outcomes

Participant User Experience Questionnaire

Evaluated using a 6-item questionnaire adapted to assess participant perception across six domains: taste perception, post-rinse taste duration, taste alteration, convenience of use, rinsing duration compliance, and perceived effectiveness on plaque reduction. Each item is measured on a 10 cm Visual Analogue Scale (VAS) ranging from 0 (most negative response/least favorable) to 100 mm (most positive response/most favorable). Individual item scores will be reported separately.

Time frame: Day 4 of Phase 1 and Day 4 of Phase 2

Data from ClinicalTrials.gov

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