Gingivitis
Conditions
Keywords
Gingivitis, hydrogen peroxide, mouth rinses, oral solutions
Brief summary
Gingivitis is a reversible inflammation of the gums caused by the accumulation of dental plaque. Without appropriate intervention-such as proper oral hygiene and plaque removal-gingivitis can progress to periodontitis, leading to clinical attachment loss, alveolar bone resorption, and ultimately tooth loss. Gingivitis can be managed with regular and proper tooth brushing and the use of interdental brushes. In cases of more extensive inflammation affecting multiple or all teeth, dental treatment may be required, including scaling, air polishing, or both. Depending on the dentist's assessment, inflamed gums may also be treated with antibiotic therapy. As an adjunctive therapy to manage inflamed gums and maintain proper oral hygiene, the use of mouth rinses or oral solutions containing chlorhexidine, hyaluronic acid, chitosan, or active oxygen (peroxide) is recommended. These agents have antimicrobial properties, help reduce plaque accumulation, and support tissue healing. Mouth rinses containing hydrogen peroxide have been used for over a century as an adjunct to mechanical plaque removal and for the prevention or management of oral infections. Despite long-term use, clinical studies on hydrogen peroxide-based mouth rinses are limited and vary in design, which makes comparison of results difficult. One of the objectives of the proposed post-marketing clinical study is to generate data on the safety and effectiveness of hydrogen peroxide mouth rinses as adjunctive therapy in the treatment of gingivitis. The study will evaluate two concentrations of hydrogen peroxide mouth rinses: 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 4 weeks as an adjunct to standard care.
Patients will use OROXID® sensitive oral solution two to three times daily for 4 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. Presence of at least 20 natural teeth. 3. Probing pocket depth less than or equal to 3 mm. 4. Presence of bleeding on probing in more than 10% of sites. 5. Mean Gingival Index (Silness & Löe) of at least 1. 6. Ability and willingness to follow oral hygiene instructions after the intervention. 7. Signed informed consent form after being informed about the study.
Exclusion criteria
1. Periodontal treatment within the last three months. 2. Diagnosis of periodontitis. 3. Use of mouth rinses or oral gels within the last month. 4. Use of antibiotic therapy within the last three months. 5. Known allergy or hypersensitivity to any components of the investigational products. 6. Ongoing treatment with antihypertensive, antilipemic, antiarrhythmic, or other cardiovascular medications. 7. Presence of systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic kidney disease, tuberculosis, or autoimmune disorders (e.g., lupus, scleroderma, Crohn's disease). 8. Use of immunosuppressive medications. 9. Ongoing orthodontic treatment, fixed orthodontic appliance, or removable denture. 10. Pregnant or breastfeeding women. 11. Smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index (GI) at Day 7 | Baseline and Day 7 | Mean change in Gingival Index (Silness and Löe) scores from baseline to day 7, 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) at Day 7 | Baseline and Day 7 | 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. |
| Bleeding on Probing (BOP) at Day 7 | Baseline and Day 7 | Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 7 days 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 |
|---|---|---|
| Rate of infection | Baseline to Day 28 | Incidence of infections in each group |
| Gingival Index (GI) at Day 14 and 28 | Baseline, Day 14, and Day 28 | Mean change in Gingival Index (Silness and Löe) scores from baseline to day 14, and 28, 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. |
| Adverse events | Baseline to Day 28 | 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. |
| Plaque Index (PI) at Day 14 and 28 | Baseline, Day 14, and Day 28 | 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. |
| Bleeding on Probing (BOP) at Day 14 and 28 | Baseline, Day 14, and Day 28 | Difference in the presence of bleeding on probing (BOP) between the two active treatment groups and the control group after 14 and 28 days 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. |
Countries
Slovenia
Contacts
Primary ContactDominika Tompa Majcen, MPharm
Outcome results
None listed