Tooth ExtrusionOroxSurgeNCT06987253
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
A study testing OROXID® forte oral solution in people with Tooth Extrusion and Wound Healing, run by ENIKAM d.o.o. at 1 site in Slovenia.
Trial summary
Oral tissue healing is significantly affected by the high bacterial load and constant mechanical stress within the oral cavity. To control bacterial colonization and support healing, both topical and systemic treatments-such as antibiotics and anti-inflammatory agents-are commonly recommended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extrusion, Wound Healing
- What is being tested?
- OROXID® forte 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
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 6 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 individuals aged 18 years or older.
- Indicated for surgical removal of an erupted or unerupted tooth and/or apicoectomy.
- Ability and willingness to comply with post-operative oral hygiene instructions.
- Signed informed consent form prior to participation in the study.
Who cannot join
- Receipt of periodontal treatment within the past 3 months.
- Use of mouthwashes or oral gels in the past month.
- Presence of active gingivitis around the tooth scheduled for extraction.
- Known allergy to any ingredients of the investigational products.
- Presence of inflammatory conditions in the oral cavity, such as lichen planus, bullous lesions, or active gingivitis.
- Immunocompromised individuals.
Show all 9Show fewer
- Known allergy to penicillin or diclofenac.
- Pregnant or breastfeeding women.
- Smokers who consume more than 15 cigarettes per day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Klinika Križaj
Muljava, Municipality of Ivančna Gorica, 1295
Tadej Dovšak Doctor of Medicine, Doctor of Dental Medicine, PhD, 0038651300415, info@klinikakrizaj.si
About this study
Oral tissue healing is significantly affected by the high bacterial load and constant mechanical stress within the oral cavity. To control bacterial colonization and support healing, both topical and systemic treatments-such as antibiotics and anti-inflammatory agents-are commonly recommended. In addition to pharmacological therapies, mouthwashes containing peroxide, hyaluronic acid, chitosan, or chlorhexidine are often used to maintain low levels of pathogenic bacteria.
However, current recommendations for mouthwash use are primarily based on their antibacterial properties in a healthy oral environment. Evidence supporting their role in promoting wound healing, particularly after oral surgery, remains limited.
Read more
OROXID® mouthwash is a medical device formulated with active oxygen (peroxide compounds). It supports the prevention and relief of inflammation in gingival and paranasal tissues through mechanical action: the release of oxygen bubbles helps cleanse tissues by removing debris. OROXID® acts locally on the mucosal microenvironment by moistening, oxygenating, and clearing away particles and dead cells. Additionally, its slightly acidic pH (between 3 and 5) helps inhibit microbial growth.
The investigators hypothesize that OROXID® may reduce post-operative side effects and complications following wisdom tooth extraction and contribute to faster wound healing.
- Conditions
- Tooth Extrusion, Wound Healing
- Being tested
- OROXID® forte oral solution, Standard of Care (SOC)
- Keywords
- Oral cavity wound, Hydrogen peroxide, Mouthwash
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 14 days as an adjunct to standard care.
Standard of Care (SOC)Other
Patients will receive standard of care meaning proper tooth brushing without the use of any mouthwash or other products aimed at reducing bacteria in the oral cavity.
| Study group | Role | What they receive |
|---|---|---|
| OROXID® forte | Experimental | Medical device: OROXID® forte oral solution Receives: Device: OROXID® forte oral solution |
| Standard of care | Other | Oral solutions are not allowed Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Landry Index
Differences in the total score of the individual components of the Modified Landry Index between the active and control groups. This entails evaluating the following parameters in a comparative manner using a dichotomic score: gingival color (0 = red, 1 = pink); granulation tissue (0 = present, 1 = absent); tissue epithelialization (0 = partial/1 = complete); swelling (0 = pres- ence, 1 = absent); bleeding on palpation (0 = present, 1 = absent); sup- puration on palpation (0 = present, 1 = absent). The total score, ranging from 0 to 6, reflects the overall quality of healing, with higher scores indicating more favorable outcomes.
Measured: 7 days
Secondary outcomes (5)
Completely Healed Wounds
Proportion of completely healed wounds at 14 days in the active versus control group.
Measured: 14 days
Mean Early Healing Index
Mean Early Healing Index (EHI) scores will be used to compare the groups. The EHI evaluates key clinical indicators of wound healing, including redness, swelling, bleeding, and epithelialization. Scores range from 0 to 5, with 0 representing very poor healing and 5 indicating excellent healing. Higher EHI scores correspond to more favorable healing outcomes.
Measured: 7 and 14 days
Plaque Index
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: 7 and 14 days
Pain Relief
Assessment of additional analgesic use (measured in days) will be conducted to compare the active and control groups.
Measured: In the first 7 days
Infection rate
Incidence of post-operative infections in each group
Measured: 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start6 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 Tooth ExtrusionStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ENIKAM d.o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tadej Dovšak, PhD, Principal investigator, Krizaj d.o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987253
- Sponsor's protocol ID
- OROXID-PR-01-25
- Acronym
- OroxSurge
- Status last verified
- Nov 2025
- First submitted
- 8 May 2025
- Last updated
- 1 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 1 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 Oral Cavity Surgery
- ClinicalTrials.gov ID
- NCT06987253
- Acronym / sponsor ID
- OroxSurge / OROXID-PR-01-25
- Conditions
- Tooth Extrusion, Wound Healing
- Keywords
- Oral cavity wound, Hydrogen peroxide, Mouthwash
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ENIKAM d.o.o.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 23 May 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.
Oral tissue healing is significantly affected by the high bacterial load and constant mechanical stress within the oral cavity. To control bacterial colonization and support healing, both topical and systemic treatments-such as antibiotics and anti-inflammatory agents-are commonly recommended. In addition to pharmacological therapies, mouthwashes containing peroxide, hyaluronic acid, chitosan, or chlorhexidine are often used to maintain low levels of pathogenic bacteria.
However, current recommendations for mouthwash use are primarily based on their antibacterial properties in a healthy oral environment. Evidence supporting their role in promoting wound healing, particularly after oral surgery, remains limited.
OROXID® mouthwash is a medical device formulated with active oxygen (peroxide compounds). It supports the prevention and relief of inflammation in gingival and paranasal tissues through mechanical action: the release of oxygen bubbles helps cleanse tissues by removing debris. OROXID® acts locally on the mucosal microenvironment by moistening, oxygenating, and clearing away particles and dead cells. Additionally, its slightly acidic pH (between 3 and 5) helps inhibit microbial growth.
The investigators hypothesize that OROXID® may reduce post-operative side effects and complications following wisdom tooth extraction and contribute to faster wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OROXID® forte | Experimental | Device: OROXID® forte oral solutionMedical device: OROXID® forte oral solution |
| Standard of care | Other | Other: Standard of Care (SOC)Oral 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 (4 listed)
- Systemically healthy individuals aged 18 years or older.
- Indicated for surgical removal of an erupted or unerupted tooth and/or apicoectomy.
- Ability and willingness to comply with post-operative oral hygiene instructions.
- Signed informed consent form prior to participation in the study.
Key exclusion criteria (9 listed)
- Receipt of periodontal treatment within the past 3 months.
- Use of mouthwashes or oral gels in the past month.
- Presence of active gingivitis around the tooth scheduled for extraction.
- Known allergy to any ingredients of the investigational products.
- Presence of inflammatory conditions in the oral cavity, such as lichen planus, bullous lesions, or active gingivitis.
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 14 days as an adjunct to standard care. | Device | OROXID® forte |
| Standard of Care (SOC)Patients will receive standard of care meaning proper tooth brushing without the use of any mouthwash or other products aimed at reducing bacteria in the oral cavity. | Other | Standard of care |
Primary outcome
Modified Landry Index
Time frame: 7 days
Differences in the total score of the individual components of the Modified Landry Index between the active and control groups. This entails evaluating the following parameters in a comparative manner using a dichotomic score: gingival color (0 = red, 1 = pink); granulation tissue (0 = present, 1 = absent); tissue epithelialization (0 = partial/1 = complete); swelling (0 = pres- ence, 1 = absent); bleeding on palpation (0 = present, 1 = absent); sup- puration on palpation (0 = present, 1 = absent). The total score, ranging from 0 to 6, reflects the overall quality of healing, with higher scores indicating more favorable outcomes.
5 secondary outcomes
Completely Healed Wounds
Time frame: 14 days
Mean Early Healing Index
Time frame: 7 and 14 days
Plaque Index
Time frame: 7 and 14 days
Pain Relief
Time frame: In the first 7 days
Infection rate
Time frame: 7 and 14 days
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 1 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.
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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.
Tadej Dovšak, PhD principal investigator
Krizaj d.o.o.
1 site 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 in people with Tooth Extrusion and Wound Healing, run by ENIKAM d.o.o. at 1 site 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 4 inclusion and 9 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 1 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 1 site 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?
Modified Landry Index (time frame: 7 days). 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 1 Dec 2025.