Plaque Induced Gingival DiseasePhase 4BHCl-PLAQUENCT07565766
Effect of Benzydamine Hydrochloride Mouthrinse on Plaque Accumulation in Periodontally Healthy Female Subjects
A Phase 4 study testing Benzydamine hydrochloride mouthrinse in people with Plaque Induced Gingival Disease and Oral Health, run by University of Zagreb at 1 site in Croatia.
Trial summary
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingival Disease, Oral Health
- What is being tested?
- Benzydamine hydrochloride mouthrinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2013to May 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- dentate subjects with at least 24 healthy teeth
- no history of periodontal disease, confirmed by a clinically healthy periodontium, defined as probing pocket depth (PPD) ≤ 3 mm and no interdental clinical attachment loss
Who cannot join
- pregnant or lactating females
- using hormonal contraceptives
- reporting systemic diseases or pharmacological treatment that could affect gingival inflammation
- use of antibiotics within 6 months before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Benzydamine Hydrochloride During Short-term Restricted Oral Hygiene: a Randomized, Placebo-controlled Trial
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.
Read the detailed description
This study is designed as a randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the effects of a benzydamine hydrochloride-containing mouthrinse on supragingival plaque accumulation and gingival inflammatory response under conditions of restricted mechanical oral hygiene. The experimental model is based on a short-term plaque regrowth protocol, enabling controlled assessment of the chemical effects of the investigational product in the absence of confounding mechanical plaque removal.
A total of 50 periodontally healthy female participants will be enrolled and randomly assigned to either the test group (benzydamine hydrochloride mouthrinse) or the control group (placebo mouthrinse). Randomization will be performed using a predefined allocation sequence to ensure balanced group distribution. Both participants and investigators will be blinded to group assignment, with the test and placebo formulations matched in color, taste, and packaging to maintain allocation concealment.
Prior to the experimental phase, all participants will receive professional dental prophylaxis to establish a standardized baseline with minimal plaque accumulation and absence of gingival inflammation. Following this, subjects will be instructed to refrain from all mechanical oral hygiene procedures, including toothbrushing and interdental cleaning, for the duration of the 3-day experimental period.
During the experimental phase, participants will use the assigned mouthrinse twice daily, rinsing with 15 mL of solution for a standardized duration according to detailed written instructions.
The investigational product contains benzydamine hydrochloride, a locally acting non-steroidal anti-inflammatory agent with analgesic and anti-inflammatory properties, which may influence gingival tissue response and potentially affect plaque accumulation dynamics. The placebo formulation is devoid of active pharmacological ingredients but is otherwise identical in formulation characteristics to ensure effective blinding.
Clinical assessments will be conducted at baseline and at the end of the 3-day experimental period. Plaque accumulation will be assessed using the Plaque Control Record (PCR), which quantifies the presence of plaque on six tooth surfaces and expresses the findings as a percentage of plaque-positive sites. Gingival inflammation will be evaluated as a secondary outcome using Bleeding on Probing (BoP), recorded dichotomously following periodontal probing.
All clinical measurements will be performed by a previously calibrated examiner using standardized instruments and probing force to ensure consistency and reproducibility of recorded data.
This study design allows for the isolation of the chemical effects of benzydamine hydrochloride by eliminating mechanical plaque control, thereby providing insight into its influence on early plaque formation and gingival inflammatory response compared to placebo. The short duration of the experimental phase ensures participant safety while allowing detection of early biological changes in plaque accumulation and gingival health.
- Conditions
- Plaque Induced Gingival Disease, Oral Health
- Being tested
- Benzydamine hydrochloride mouthrinse, Placebo mouthrinse
- Keywords
- Benzydamine Hydrochloride, Randomized Controlled Trial, Dental plaque, Oral hygiene, Anti-inflammatory Agent
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzydamine hydrochloride mouthrinseDrug
Participants assigned to the intervention arm will use a mouthrinse containing benzydamine hydrochloride twice daily. A volume of 15 mL will be used per rinse, following a standardized rinsing duration in accordance with the manufacturer's instructions. During the 3-day experimental period, participants will refrain from all mechanical oral hygiene measures to allow assessment of the chemical effects of the mouthrinse on plaque accumulation and gingival inflammation.
Placebo mouthrinseOther
Participants assigned to the placebo arm will use a mouthrinse without active pharmacological ingredients, formulated to match the test product in color, taste, and packaging to ensure blinding. The mouthrinse will be used twice daily in a volume of 15 mL, following a standardized rinsing duration in accordance with the manufacturer's instructions. Mechanical oral hygiene measures will be suspended throughout the 3-day experimental period.
| Study group | Role | What they receive |
|---|---|---|
| Benzydamine Hydrochloride mouthrinse | Experimental | Experimental arm participants will use the assigned mouthrinse containing benzydamine hydrochloride twice daily, rinsing with 15 mL of solution for a standardized duration according to the manufacturer's instructions. Receives: Drug: Benzydamine hydrochloride mouthrinse |
| Placebo mouthrinse | Placebo comparator | Placebo mouthwash arm participants will use the assigned placebo mouthrinse, formulated to be identical in color, taste, and packaging to ensure effective allocation concealment. The mouthrinse will be used twice daily, with 15 mL of solution, following a standardized rinsing duration in accordance with the manufacturer's instructions. Receives: Other: Placebo mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-day plaque accumulation assessed by Plaque Control Record (PCR)
Plaque accumulation will be evaluated using the Plaque Control Record (PCR), which assesses the presence or absence of supragingival plaque on six surfaces of each tooth. The results will be expressed as the percentage of plaque-positive surfaces relative to the total number of examined surfaces, providing a quantitative measure of plaque regrowth under conditions of suspended mechanical oral hygiene.
Measured: Baseline (Day 0) and Day 3
Secondary outcomes (1)
3-day gingival inflammation assessed by Bleeding on Probing (BoP)
Gingival inflammation will be assessed using Bleeding on Probing (BoP), recorded dichotomously (presence/absence of bleeding) following gentle probing of the gingival sulcus at standardized sites. The outcome will be expressed as the percentage of bleeding-positive sites, reflecting the degree of gingival inflammatory response.
Measured: Baseline (Day 0) and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque Induced Gingival DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Puhar, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565766
- Sponsor's protocol ID
- 05-PA-26-22/13
- Acronym
- BHCl-PLAQUE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puhar I, Palesko Tubikanec T, Glavina S, Borovac M, Vrazic D, Badovinac A, Music L. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals (Basel). 2026 Jun 30;19(7):1013. doi: 10.3390/ph19071013.
PubMed 42515697
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Benzydamine Hydrochloride During Short-term Restricted Oral Hygiene: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07565766
- Acronym / sponsor ID
- BHCl-PLAQUE / 05-PA-26-22/13
- Conditions
- Plaque Induced Gingival Disease, Oral Health
- Keywords
- Benzydamine Hydrochloride, Randomized Controlled Trial, Dental plaque, Oral hygiene, Anti-inflammatory Agent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 May 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.
The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.
Detailed description
This study is designed as a randomized, double-blind, placebo-controlled, parallel-group clinical trial to evaluate the effects of a benzydamine hydrochloride-containing mouthrinse on supragingival plaque accumulation and gingival inflammatory response under conditions of restricted mechanical oral hygiene. The experimental model is based on a short-term plaque regrowth protocol, enabling controlled assessment of the chemical effects of the investigational product in the absence of confounding mechanical plaque removal.
A total of 50 periodontally healthy female participants will be enrolled and randomly assigned to either the test group (benzydamine hydrochloride mouthrinse) or the control group (placebo mouthrinse). Randomization will be performed using a predefined allocation sequence to ensure balanced group distribution. Both participants and investigators will be blinded to group assignment, with the test and placebo formulations matched in color, taste, and packaging to maintain allocation concealment.
Prior to the experimental phase, all participants will receive professional dental prophylaxis to establish a standardized baseline with minimal plaque accumulation and absence of gingival inflammation. Following this, subjects will be instructed to refrain from all mechanical oral hygiene procedures, including toothbrushing and interdental cleaning, for the duration of the 3-day experimental period.
During the experimental phase, participants will use the assigned mouthrinse twice daily, rinsing with 15 mL of solution for a standardized duration according to detailed written instructions.
The investigational product contains benzydamine hydrochloride, a locally acting non-steroidal anti-inflammatory agent with analgesic and anti-inflammatory properties, which may influence gingival tissue response and potentially affect plaque accumulation dynamics. The placebo formulation is devoid of active pharmacological ingredients but is otherwise identical in formulation characteristics to ensure effective blinding.
Clinical assessments will be conducted at baseline and at the end of the 3-day experimental period. Plaque accumulation will be assessed using the Plaque Control Record (PCR), which quantifies the presence of plaque on six tooth surfaces and expresses the findings as a percentage of plaque-positive sites. Gingival inflammation will be evaluated as a secondary outcome using Bleeding on Probing (BoP), recorded dichotomously following periodontal probing.
All clinical measurements will be performed by a previously calibrated examiner using standardized instruments and probing force to ensure consistency and reproducibility of recorded data.
This study design allows for the isolation of the chemical effects of benzydamine hydrochloride by eliminating mechanical plaque control, thereby providing insight into its influence on early plaque formation and gingival inflammatory response compared to placebo. The short duration of the experimental phase ensures participant safety while allowing detection of early biological changes in plaque accumulation and gingival health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzydamine Hydrochloride mouthrinse | Experimental | Drug: Benzydamine hydrochloride mouthrinseExperimental arm participants will use the assigned mouthrinse containing benzydamine hydrochloride twice daily, rinsing with 15 mL of solution for a standardized duration according to the manufacturer's instructions. |
| Placebo mouthrinse | Placebo comparator | Other: Placebo mouthrinsePlacebo mouthwash arm participants will use the assigned placebo mouthrinse, formulated to be identical in color, taste, and packaging to ensure effective allocation concealment. The mouthrinse will be used twice daily, with 15 mL of solution, following a standardized rinsing duration in accordance with the manufacturer's instructions. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- dentate subjects with at least 24 healthy teeth
- no history of periodontal disease, confirmed by a clinically healthy periodontium, defined as probing pocket depth (PPD) ≤ 3 mm and no interdental clinical attachment loss
Key exclusion criteria (4 listed)
- pregnant or lactating females
- using hormonal contraceptives
- reporting systemic diseases or pharmacological treatment that could affect gingival inflammation
- use of antibiotics within 6 months before the study
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 |
|---|---|---|
| Benzydamine hydrochloride mouthrinseParticipants assigned to the intervention arm will use a mouthrinse containing benzydamine hydrochloride twice daily. A volume of 15 mL will be used per rinse, following a standardized rinsing duration in accordance with the manufacturer's instructions. During the 3-day experimental period, participants will refrain from all mechanical oral hygiene measures to allow assessment of the chemical effects of the mouthrinse on plaque accumulation and gingival inflammation. | Drug | Benzydamine Hydrochloride mouthrinse |
| Placebo mouthrinseParticipants assigned to the placebo arm will use a mouthrinse without active pharmacological ingredients, formulated to match the test product in color, taste, and packaging to ensure blinding. The mouthrinse will be used twice daily in a volume of 15 mL, following a standardized rinsing duration in accordance with the manufacturer's instructions. Mechanical oral hygiene measures will be suspended throughout the 3-day experimental period. | Other | Placebo mouthrinse |
Primary outcome
3-day plaque accumulation assessed by Plaque Control Record (PCR)
Time frame: Baseline (Day 0) and Day 3
Plaque accumulation will be evaluated using the Plaque Control Record (PCR), which assesses the presence or absence of supragingival plaque on six surfaces of each tooth. The results will be expressed as the percentage of plaque-positive surfaces relative to the total number of examined surfaces, providing a quantitative measure of plaque regrowth under conditions of suspended mechanical oral hygiene.
1 secondary outcome
3-day gingival inflammation assessed by Bleeding on Probing (BoP)
Time frame: Baseline (Day 0) and Day 3
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 4 May 2026.
- Derived from this study: PubMed 42515697Puhar I, Palesko Tubikanec T, Glavina S, Borovac M, Vrazic D, Badovinac A, Music L. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals (Basel). 2026 Jun 30;19(7):1013. doi: 10.3390/ph19071013.
- Individual participant dataSharing planned: No
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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 Benzydamine hydrochloride mouthrinse in people with Plaque Induced Gingival Disease and Oral Health, run by University of Zagreb at 1 site in Croatia.
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 4 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 4 May 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 Croatia. 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. Some participants in this study may receive a placebo. 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?
3-day plaque accumulation assessed by Plaque Control Record (PCR) (time frame: Baseline (Day 0) and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565766, which also lists 1 linked publication.
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 4 May 2026.