OROXID® mouthwash to support healing after oral surgery
Official title: Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
Run by ENIKAM d.o.o. · NCT06987253 · Data updated 2026-11-12
This trial will test whether OROXID® mouthwash helps wounds heal faster and reduces inflammation after tooth extraction or apicoectomy in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | ENIKAM d.o.o. Industry-sponsored |
| Locations | 1 site (Muljava, Municipality of Ivančna Gorica) |
| Status | Recruiting |
| Started | November 6, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2026 |
| Registry record updated | December 1, 2025 |
| Trial ID | NCT06987253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Systemically healthy adults (18+) scheduled for surgical tooth removal or apicoectomy who can comply with post-operative oral hygiene instructions are the intended participants.
✕Probably not a fit
People who are immunocompromised, pregnant or breastfeeding, have active oral inflammatory conditions, recent periodontal treatment, or who smoke heavily are excluded and may not receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares OROXID® forte oral solution (an active-oxygen/peroxide mouthwash) plus standard care to standard care alone in adults undergoing extraction of an erupted or unerupted tooth or apicoectomy. The product is intended to mechanically cleanse tissues by releasing oxygen bubbles that remove debris and reduce bacterial load, with safety and wound-healing outcomes monitored after surgery. Eligible participants are systemically healthy adults who can follow post-operative oral hygiene instructions; common exclusions include recent periodontal treatment, active oral inflammatory lesions, immunocompromise, pregnancy, breastfeeding, and heavy smoking. The study is conducted at a single site and collects clinical wound-healing and adverse-event data to compare the two approaches.
Why it matters
Potential benefit: If successful, OROXID® could shorten healing time and reduce post-operative inflammation or infection after oral cavity surgery.
How similar studies have gone: Mouthwashes containing peroxide or other antimicrobials are commonly used to control bacteria, but high-quality evidence that they directly improve post-surgical oral wound healing is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Systemically healthy individuals aged 18 years or older. 2. Indicated for surgical removal of an erupted or unerupted tooth and/or apicoectomy. 3. Ability and willingness to comply with post-operative oral hygiene instructions. 4. Signed informed consent form prior to participation in the study. Exclusion Criteria: 1. Receipt of periodontal treatment within the past 3 months. 2. Use of mouthwashes or oral gels in the past month. 3. Presence of active gingivitis around the tooth scheduled for extraction. 4. Known allergy to any ingredients of the investigational products. 5. Presence of inflammatory conditions in the oral cavity, such as lichen planus, bullous lesions, or active gingivitis. 6. Immunocompromised individuals. 7. Known allergy to penicillin or diclofenac. 8. Pregnant or breastfeeding women. 9. Smokers who consume more than 15 cigarettes per day.
Where it's running
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Klinika Križaj
Muljava, Municipality of Ivančna Gorica, Slovenia Recruiting
Study contacts
- Principal investigator: Tadej Dovšak, PhD — Krizaj d.o.o.
- Study coordinator: Dominika Tompa Majcen MPharm
- Email: dominika@enikam-oxy.com
- Phone: +386 40 530 663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.