Gingival InflammationPhase 4NCT07824388
Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash
A Phase 4 study testing Bioflavonoid mouthwash and Chlorhexidine 0.12% mouthwash in people with Gingival Inflammation and Dental Plaque Accumulation, run by University of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation, Dental Plaque Accumulation
- What is being tested?
- Bioflavonoid mouthwash and Chlorhexidine 0.12% mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2026to 13 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals with > 20 teeth present, with a minimum of 5 teeth per quadrant.
- Individuals >18 years of age
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontològic Universitat de Barcelona
Barcelona, Catalonia, 08970
About this study
Official title: Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash: a Randomized, Double-blind, Controlled, Crossover Clinical Trial
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
- Gingival Inflammation, Dental Plaque Accumulation
- Being tested
- Bioflavonoid mouthwash, Chlorhexidine 0.12% mouthwash
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioflavonoid mouthwashDrug
Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.
Chlorhexidine 0.12% mouthwashDrug
Rinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bioflavonoid mouthwash; Drug: Chlorhexidine 0.12% mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1 and Day 4 of Phase 1; Day 1 and Day 4 of Phase 2
Secondary outcomes (1)
Participant User Experience Questionnaire
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.
Measured: Day 4 of Phase 1 and Day 4 of Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start2 Mar 2026
- Primary completion10 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayra Schemel Suarez, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824388
- Sponsor's protocol ID
- 59/2025
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-plaque Effect of a Bioflavonoid-based Antiseptic Mouthwash: a Randomized, Double-blind, Controlled, Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07824388
- Acronym / sponsor ID
- 59/2025
- Conditions
- Gingival Inflammation, Dental Plaque Accumulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (Bioflavonoid moutwash then Chlorhexidine) | Experimental | Drug: Bioflavonoid mouthwash, Drug: Chlorhexidine 0.12% mouthwashParticipants 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% mouthwashParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with > 20 teeth present, with a minimum of 5 teeth per quadrant.
- Individuals >18 years of age
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioflavonoid mouthwashRinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence. | Drug | Sequence 1 (Bioflavonoid moutwash then Chlorhexidine), Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid) |
| Chlorhexidine 0.12% mouthwashRinsed twice daily for 4 consecutive days. Abstinence from mechanical oral hygiene during use. 15-day washout before/after sequence. | Drug | Sequence 1 (Bioflavonoid moutwash then Chlorhexidine), Sequence 2 (Chlorhexidine mouthwash then Bioflavonoid) |
Primary outcome
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.
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.
1 secondary outcome
Participant User Experience Questionnaire
Time frame: Day 4 of Phase 1 and Day 4 of Phase 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Gingival Inflammation
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioflavonoid mouthwash and Chlorhexidine 0.12% mouthwash in people with Gingival Inflammation and Dental Plaque Accumulation, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total plaque accumulation (time frame: Day 4 of Phase 1 and Day 4 of Phase 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.