GingivitisOroxGingNCT07270705
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis
A study testing OROXID® forte oral solution and OROXID® sensitive oral solution in people with Gingivitis, run by ENIKAM d.o.o. at 2 sites in Slovenia.
Trial summary
Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- OROXID® forte oral solution and OROXID® sensitive oral solution
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSlovenia
- Study dates
- 22 Nov 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy participants aged 18 years or older.
- Presence of at least 20 natural teeth.
- Probing pocket depth less than or equal to 3 mm.
- Presence of bleeding on probing in more than 10% of sites.
- Mean Gingival Index (Silness \& Löe) of at least 1.
- Ability and willingness to follow oral hygiene instructions after the intervention.
- Signed informed consent form after being informed about the study.
Who cannot join
- Periodontal treatment within the last three months.
- Diagnosis of periodontitis.
- Use of mouth rinses or oral gels within the last month.
- Use of antibiotic therapy within the last three months.
- Known allergy or hypersensitivity to any components of the investigational products.
- Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications.
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- Presence of systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic kidney disease, tuberculosis, or autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease).
- Use of immunosuppressive medications.
- Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture.
- Pregnant or breastfeeding women.
- Smokers.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia2 sites, 2 recruiting
- Recruiting
Klinika Križaj Ljubljana
Ljubljana, 1000
Urban Matoh, DMD, 00385651224900, urban.matoh@siol.net
Urban Matoh, DMD
- Recruiting
Ustna medicina d.o.o.
Ljubljana, 1000
Sebastjan Perko, PhD, DMD, 0038612323235, info@ustna-medicina.com
Sebastjan Perko, PhD, DMD
About this study
Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy.
As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult.
One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).
- Conditions
- Gingivitis
- Being tested
- OROXID® forte oral solution, OROXID® sensitive oral solution, Standard of Care
- Keywords
- Gingivitis, hydrogen peroxide, mouth rinses, oral solutions
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROXID® forte oral solutionDevice
Patients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care.
OROXID® sensitive oral solutionDevice
Patients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care.
Standard of CareOther
Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.
| Study group | Role | What they receive |
|---|---|---|
| OROXID® forte oral solution | Experimental | Medical device: OROXID® forte oral solution Receives: Device: OROXID® forte oral solution |
| OROXID® sensitive oral solution | Experimental | Medical device: OROXID® sensitive oral solution Receives: Device: OROXID® sensitive oral solution |
| Standard of Care | Other | Oral solutions are not allowed Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (GI) at Day 7
Mean change in Gingival Index (Silness and Löe) scores from baseline to day 7, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.
Measured: Baseline and Day 7
Plaque Index (PI) at Day 7
Differences in Plaque Index (PI) scores between the active and control groups will be evaluated using the Silness and Löe Plaque Index. This index assesses the thickness of dental plaque along the gingival margin based on the following scoring criteria: Score 0 = No plaque score; 1 = Mild plaque along the gingival margin; Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free; Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque. Higher scores indicate poorer oral hygiene and greater plaque accumulation.
Measured: Baseline and Day 7
Bleeding on Probing (BOP) at Day 7
Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 7 days of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.
Measured: Baseline and Day 7
Secondary outcomes (5)
Gingival Index (GI) at Day 14 and 28
Mean change in Gingival Index (Silness and Löe) scores from baseline to day 14, and 28, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.
Measured: Baseline, Day 14, and Day 28
Plaque Index (PI) at Day 14 and 28
Differences in Plaque Index (PI) scores between the active and control groups will be evaluated using the Silness and Löe Plaque Index. This index assesses the thickness of dental plaque along the gingival margin based on the following scoring criteria: Score 0 = No plaque score; 1 = Mild plaque along the gingival margin; Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free; Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque. Higher scores indicate poorer oral hygiene and greater plaque accumulation.
Measured: Baseline, Day 14, and Day 28
Bleeding on Probing (BOP) at Day 14 and 28
Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 14 and 28 days of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.
Measured: Baseline, Day 14, and Day 28
Rate of infection
Incidence of infections in each group
Measured: Baseline to Day 28
Adverse events
Number and percentage of participants experiencing adverse events (AEs) related to the use of OROXID® forte or OROXID® sensitive during the 12-week study period. The nature, severity, and relationship of each AE to the study product will be recorded and analyzed.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start22 Nov 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ENIKAM d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastjan Perko, PhD, DMD, Principal investigator, Ustna medicina d.o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270705
- Sponsor's protocol ID
- OROXID-PR-03-25
- Acronym
- OroxGing
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As a company operating under the jurisdiction of the EU, the organization is subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. Individual Participant Data (IPD) from clinical trials is considered sensitive personal data under GDPR.Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, the sharing of IPD is not permitted.For this reason, and to ensure full compliance with EU data protection regulations while safeguarding the privacy and rights of study participants, individual-level data cannot currently be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT07270705
- Acronym / sponsor ID
- OroxGing / OROXID-PR-03-25
- Conditions
- Gingivitis
- Keywords
- Gingivitis, hydrogen peroxide, mouth rinses, oral solutions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ENIKAM d.o.o.Industry (pharma, biotech, devices)
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Dec 2025 (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.
Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy.
As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult.
One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OROXID® forte oral solution | Experimental | Device: OROXID® forte oral solutionMedical device: OROXID® forte oral solution |
| OROXID® sensitive oral solution | Experimental | Device: OROXID® sensitive oral solutionMedical device: OROXID® sensitive oral solution |
| Standard of Care | Other | Other: Standard of CareOral solutions are not allowed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systemically healthy participants aged 18 years or older.
- Presence of at least 20 natural teeth.
- Probing pocket depth less than or equal to 3 mm.
- Presence of bleeding on probing in more than 10% of sites.
- Mean Gingival Index (Silness \& Löe) of at least 1.
Key exclusion criteria (11 listed)
- Periodontal treatment within the last three months.
- Diagnosis of periodontitis.
- Use of mouth rinses or oral gels within the last month.
- Use of antibiotic therapy within the last three months.
- Known allergy or hypersensitivity to any components of the investigational products.
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 |
|---|---|---|
| OROXID® forte oral solutionPatients will use OROXID® forte oral solution two to three times daily for 4 weeks as an adjunct to standard care. | Device | OROXID® forte oral solution |
| OROXID® sensitive oral solutionPatients will use OROXID® sensitive oral solution two to three times daily for 4 weeks as an adjunct to standard care. | Device | OROXID® sensitive oral solution |
| Standard of CarePatients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load. | Other | Standard of Care |
Primary outcome
Gingival Index (GI) at Day 7
Time frame: Baseline and Day 7
Mean change in Gingival Index (Silness and Löe) scores from baseline to day 7, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing.
Plaque Index (PI) at Day 7
Time frame: Baseline and Day 7
Differences in Plaque Index (PI) scores between the active and control groups will be evaluated using the Silness and Löe Plaque Index. This index assesses the thickness of dental plaque along the gingival margin based on the following scoring criteria: Score 0 = No plaque score; 1 = Mild plaque along the gingival margin; Score 2 =Moderate layer of plaque along gingival margin, interdental spaces free; Score 3 = Abundant plaque along the gingival margin, interdental spaces filled with plaque. Higher scores indicate poorer oral hygiene and greater plaque accumulation.
Bleeding on Probing (BOP) at Day 7
Time frame: Baseline and Day 7
Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 7 days of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease.
5 secondary outcomes
Gingival Index (GI) at Day 14 and 28
Time frame: Baseline, Day 14, and Day 28
Plaque Index (PI) at Day 14 and 28
Time frame: Baseline, Day 14, and Day 28
Bleeding on Probing (BOP) at Day 14 and 28
Time frame: Baseline, Day 14, and Day 28
Rate of infection
Time frame: Baseline to Day 28
Adverse events
Time frame: Baseline to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. As a company operating under the jurisdiction of the EU, the organization is subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. Individual Participant Data (IPD) from clinical trials is considered sensitive personal data under GDPR.Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, the sharing of IPD is not permitted.For this reason, and to ensure full compliance with EU data protection regulations while safeguarding the privacy and rights of study participants, individual-level data cannot currently be shared.
Related trials for Gingivitis
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A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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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.
Sebastjan Perko, PhD, DMD principal investigator
Ustna medicina d.o.o.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OROXID® forte oral solution and OROXID® sensitive oral solution in people with Gingivitis, run by ENIKAM d.o.o. at 2 sites in Slovenia.
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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominika Tompa Majcen, MPharm (+386 40 530 663, dominika@enikam-oxy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (GI) at Day 7 (time frame: Baseline and Day 7). The study lists 3 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 8 Dec 2025.