periodontal disease periodontal disease periodontitis
Conditions
Interventions
User
- Recruitment of patients: patients who meet the inclusion criteria will be
asked if they want to participate in this study (thinking period 2 weeks). They
will be provided with the product's f
Sponsors
Universiteit van Amsterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Adults above the age of 18 willing to sign the informed consent and comply with all the recall appointments - No antibiotic therapy in the past 6 months - No previous periodontal treatment, besides maintenance treatments at the oral hygienist/dentist - Diagnosed with stage III or stage IV periodontitis (pockets > 5mm) - Radiographic status of the entire mouth (multiple smaller radiographs; peri-apical and bitewings)
Exclusion criteria
Exclusion criteria: - Pregnancy or nursing - Known hypersensitivity to any of the device*s components as listed on the user leaflet - Uncontrolled diabetes (HbA1c >= 7), rheumatoid arthritis, or other chronic disesses associated with immunosuppression - History of radiotherapy or chemotherapy the last 12 months - Mental disorders - Patients undergoing orthodontic treatment - Active carious and/or endodontic-periodontic lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is a proteomic analysis of the patients' gingival crevicular fluid so that we can understand in depth how (and if) the gel promotes soft tissue healing after standard non-surgical periodontal treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes of our study are the clinical periodontal markers, which will be measured twice (baseline and control after 6 weeks): Probing Pocket Depth (PPD), Bleeding On Probing (BOP), Clinical Attachment Loss (CAL). | — |
Countries
Netherlands
Outcome results
None listed