OROXID® mouthwash to support healing after oral surgery
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
This trial will test whether OROXID® mouthwash helps wounds heal faster and reduces inflammation after tooth extraction or apicoectomy in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ENIKAM d.o.o. Industry-sponsored |
| Locations | 1 site (Muljava, Municipality of Ivančna Gorica) |
| Trial ID | NCT06987253 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Muljava, Municipality of Ivančna Gorica
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.