Dental Plaque Accumulation, Gingival Inflammation
Conditions
Brief 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.
Interventions
DRUGBioflavonoid mouthwash
Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.
Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed