Tooth Extrusion, Wound Healing
Conditions
Keywords
Oral cavity wound, Hydrogen peroxide, Mouthwash
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 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.
Interventions
Patients will use OROXID® forte oral solution two to three times daily for 14 days as an adjunct to standard care.
OTHERStandard 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.
Sponsors
ENIKAM d.o.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Landry Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completely Healed Wounds | 14 days | Proportion of completely healed wounds at 14 days in the active versus control group. |
| Mean Early Healing Index | 7 and 14 days | 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. |
| Plaque Index | 7 and 14 days | 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. |
| Pain Relief | In the first 7 days | Assessment of additional analgesic use (measured in days) will be conducted to compare the active and control groups. |
| Infection rate | 7 and 14 days | Incidence of post-operative infections in each group |
Countries
Slovenia
Contacts
Primary ContactDominika Tompa Majcen MPharm
Backup ContactDominika Tompa Majcen
Outcome results
None listed