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

NCT07824388 — Phase 4, Completed, 24 participants, University of Barcelona

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

Registry	NCT07824388
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	24 (Actual)
Sponsor	University of Barcelona (Other)
Conditions	Gingival Inflammation, Dental Plaque Accumulation
Interventions	Bioflavonoid mouthwash, Chlorhexidine 0.12% mouthwash (Drug)
Dates	start 2026-03-02, primary completion 2026-07-10, completion 2026-07-13, first posted 2026-09-17, last updated 2026-09-17
Locations	1 site in Spain

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Sequence 1 (Bioflavonoid moutwash then Chlorhexidine)	Experimental	Drug: Bioflavonoid mouthwash; Drug: Chlorhexidine 0.12% mouthwash	Participants receive Bioflavonoid mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 2.
Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)	Active comparator	Drug: Bioflavonoid mouthwash; Drug: Chlorhexidine 0.12% mouthwash	Participants receive Chlorhexidine 0.12% mouthwash twice daily for 4 days in Phase 1, undergo a 15-day washout period, and then receive Bioflavonoid mouthwash twice daily for 4 days in Phase 2.

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.

+Outcome measures

Primary outcomes

Total plaque accumulation [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.
Gingival Inflammation Score [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

Participant User Experience Questionnaire [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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)

Facility	City	Country	Status
Hospital Odontològic Universitat de Barcelona	Barcelona, Catalonia	Spain