Actively Recruiting
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients Undergoing Oral Cavity Surgery
Led by ENIKAM d.o.o. · Updated on 2025-12-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of OROXID® oral solution on healing and inflammation after oral cavity surgery, such as wisdom tooth extraction. The study aims to assess whether this medical device, which releases oxygen bubbles to cleanse tissues and inhibit microbial growth, can reduce post-operative side effects and promote faster wound healing. Current mouthwash recommendations focus mainly on antibacterial properties in healthy mouths, with limited evidence on wound healing support after surgery. Participants will be randomly assigned to use either OROXID® forte oral solution or standard care without any mouthwash. Those in the OROXID® group will use the oral solution two to three times daily for 14 days alongside proper tooth brushing. The standard care group will maintain oral hygiene without any antibacterial mouthwashes or products. This design helps compare the medical device's impact on healing and infection rates after surgery. During the 14-day study, participants will be monitored for wound healing using the Modified Landry Index at 7 days and other healing and plaque assessments at 7 and 14 days. Pain relief and infection rates will also be tracked in the first two weeks after surgery. The study includes regular evaluations to measure healing progress and side effects while ensuring participants follow oral hygiene instructions. The total duration of participation is about two weeks post-surgery.
CONDITIONS
Brief Title
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Oral Cavity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy individuals aged 18 years or older
- Scheduled for surgical removal of an erupted or unerupted tooth and/or apicoectomy
- Able and willing to comply with post-operative oral hygiene instructions
- Signed informed consent form before participation
You will not qualify if you...
- Periodontal treatment received 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 in the investigational products
- Inflammatory oral conditions such as lichen planus, bullous lesions, or active gingivitis
- Immunocompromised individuals
- Known allergy to penicillin or diclofenac
- Pregnant or breastfeeding women
- Smoking more than 15 cigarettes per day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo oral cavity surgery and receive immediate post-operative care.
1 visit (in-person)
Duration - 14 days
Participants use OROXID® forte oral solution two to three times daily for 14 days as an adjunct to standard care or receive standard care without oral solutions.
Follow-up visits at 7 and 14 days post-surgery
Trial Site Locations
Total: 1 location
1
Klinika Križaj
Muljava, Municipality of Ivančna Gorica, Slovenia, 1295
Actively Recruiting
Research Team
D
Dominika Tompa Majcen MPharm
D
Dominika Tompa Majcen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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