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Completed

NCT Number: NCT07824388

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

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.

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Key information

Conditions

Gingival Inflammation Dental Plaque Accumulation Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Odontològic Universitat de Barcelona

Barcelona, Catalonia, 08970, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioflavonoid mouthwash

Drug

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

Chlorhexidine 0.12% mouthwash

Drug

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

Primary outcomes

  1. Total plaque accumulation

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

    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.

  2. Gingival Inflammation Score

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

    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.

Secondary outcomes

  1. Participant User Experience Questionnaire

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

    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.

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash: a Randomized, Double-blind, Controlled, Crossover Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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