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Completed
NCT07824388
Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash
Conditions: Gingival Inflammation, Dental Plaque Accumulation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 24
Sponsor: University of Barcelona
Location: Hospital Odontològic Universitat de Barcelona Barcelona Catalonia
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07824388). StuddyBuddy aggregates publicly available trial information.