Status:
RECRUITING
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
Lead Sponsor:
ENIKAM d.o.o.
Conditions:
Tooth Extrusion
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Known allergy to penicillin or diclofenac.
- Pregnant or breastfeeding women.
- Smokers who consume more than 15 cigarettes per day.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06987253
Start Date
November 6 2025
End Date
May 31 2026
Last Update
December 1 2025
Active Locations (1)
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1
Klinika Križaj
Muljava, Občina Ivančna Gorica, Slovenia, 1295