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

NCT07824388 | Completed Phase 4

• 1 other identifier: 59/2025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque Accumulation; Gingival Inflammation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 and Day 4 of Phase 1; Day 1 and Day 4 of Phase 2

Secondary Outcomes (1)

• Participant User Experience Questionnaire

  Day 4 of Phase 1 and Day 4 of Phase 2

Study Arms (2)

Sequence 1 (Bioflavonoid moutwash then Chlorhexidine)

EXPERIMENTAL

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.

Drug: Bioflavonoid mouthwash; Drug: Chlorhexidine 0.12% mouthwash

Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)

ACTIVE COMPARATOR

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.

Drug: Bioflavonoid mouthwash; Drug: Chlorhexidine 0.12% mouthwash

Interventions

Bioflavonoid mouthwash DRUG

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

Sequence 1 (Bioflavonoid moutwash then Chlorhexidine); Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)

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.

Sequence 1 (Bioflavonoid moutwash then Chlorhexidine); Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with \> 20 teeth present, with a minimum of 5 teeth per quadrant.
• Individuals \>18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

Barcelona, Catalonia, 08970, Spain

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Chlorhexidine; Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDS

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: March 2, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 13, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)