Periodontal Disease
Conditions
Keywords
Periodontal Disease, hydrogen peroxide, mouth rinses
Brief summary
Periodontitis is a chronic, irreversible inflammatory disease affecting the supporting structures of the teeth. It is most commonly caused by bacteria in dental plaque, also known as biofilm. The disease typically begins as gingivitis, a reversible inflammation of the gums resulting from plaque accumulation. Without appropriate intervention-such as maintaining proper oral hygiene and removing plaque-gingivitis can progress to periodontitis, leading to the loss of clinical attachment, alveolar bone resorption, and eventually tooth loss. Early diagnosis and regular treatment of periodontal disease are essential to prevent disease progression. The treatment of periodontitis is primarily causal and involves the mechanical removal of plaque. Initial therapy is non-surgical, consisting of scaling and root planing, and may be followed by surgical procedures if required. In addition to mechanical cleaning, increasing attention has been given to adjunctive, non-invasive therapies such as mouth rinses or oral solutions containing chlorhexidine or hydrogen peroxide. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Hydrogen peroxide mouth rinses have been used for more than a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. However, despite their long history of use, clinical studies evaluating hydrogen peroxide-based mouth rinses remain limited and heterogeneous in design, which makes it difficult to compare findings across studies. The objective of this post-marketing clinical study is to generate additional data on the safety and efficacy of a hydrogen peroxide mouth rinse as an adjunctive therapy in the treatment of periodontitis. The study will evaluate two hydrogen peroxide concentrations: a 1.5% solution (Oroxid® sensitive) and a 3% solution (Oroxid® forte).
Interventions
Patients will use OROXID® forte oral solution two to three times daily for 12 weeks as an adjunct to standard care.
Patients will use OROXID® sensitive oral solution two to three times daily for 12 weeks as an adjunct to standard care.
OTHERStandard of Care
Patients will receive standard of care, consisting of proper tooth brushing without the use of any mouthwash or other products intended to maintain oral hygiene or reduce oral bacterial load.
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 participants aged 18 years or older. 2. Generalized periodontitis, Stage III, Grade B. 3. Presence of three or more periodontal pockets deeper than 5 mm. 4. At least 16 natural teeth (excluding wisdom teeth). 5. Ability to comply with oral hygiene instructions following the intervention. 6. Signed informed consent form after being fully informed about the study.
Exclusion criteria
1. Periodontal treatment within the past six months. 2. Dental procedures (surgery, professional cleaning, scaling and root planing, laser therapy, piezotome) within the past six months. 3. Periodontitis, Stage IV. 4. Use of mouth rinses or oral gels within the past month. 5. Use of antibiotic therapy within the past three months. 6. Ongoing therapy with antihypertensives, antilipemics, antiarrhythmics, or other cardiovascular medications. 7. Systemic diseases such as diabetes, HIV/AIDS, liver diseases, chronic kidney disease, tuberculosis, and autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease). 8. History of cardiovascular diseases, including acute myocardial infarction, angina pectoris, heart failure, atrial fibrillation, atrioventricular block, peripheral artery disease, or stroke. 9. Therapy with immunosuppressive agents. 10. Allergy to any ingredients of the study products. 11. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth | Baseline and Week 12 | Mean change in probing depth (measured in millimeters) from baseline to Week 12, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. Probing Depth is the measurement of the distance from the gingival margin to the bottom of the periodontal pocket using a periodontal probe. Values typically range from 1-3 mm (healthy) to ≥5 mm (indicative of periodontal disease), with deeper pockets reflecting more severe attachment loss. |
| Bleeding on Probing (BOP) | Baseline and Week 12 | Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 12 weeks of treatment. BOP evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index (GI) | Baseline and Week 12 | Mean change in Gingival Index (Silness and Löe) scores from baseline to Week 12, comparing the two active treatment groups (OROXID® forte and OROXID® sensitive) with the control group. The Gingival Index (GI) evaluates the severity of gingival inflammation on a scale of 0 to 3, based on redness, swelling, and bleeding on probing. |
| Plaque Index (PI) | Baseline and Week 12 | 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. |
| Rate of infection | Up to week 12 | Incidence of infections in each group |
| Adverse events | Throughout the 12-week study period | Number and percentage of participants experiencing adverse events (AEs) related to the use of OROXID® forte or OROXID® sensitive during the 12-week study period. The nature, severity, and relationship of each AE to the study product will be recorded and analyzed. |
Countries
Slovenia
Contacts
Primary ContactDominika Tompa Majcen, MPharm
Outcome results
None listed