Surgical regenerative treatment of infrabony periodontal defects Oral Health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65 years with periodontitis Stage II-IV 2. Presence of at least one infrabony defect of at least 4mm in depth 3. No systemic conditions affecting periodontal healing 4. Non-smokers/smoking up to 8 cigarettes a day
Exclusion criteria
Exclusion criteria: 1. Horizontal defects 2. Pregnancy or lactation 3. Allergies to study materials 4. Smoking more than 10 cigarettes/ day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical attachment level (CAL) gain measured using calibrated periodontal probe (PCP-UNC15 HuFriedy )with a consistent reference point (CEJ) at 6- and 12-months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Probing depth (PD) is measured using a calibrated manual periodontal probe with measurements taken at six sites per tooth at baseline, 6 months, and 12 months post-surgery 2. Reduction of BOP is measured using the calculated percentage of sites with BOP (BOP Percentage = Total number of sites probed / Number of sites with bleeding × 100) at baseline, 6 months, and 12 months post-surgery 3. Radiographic bone fill is measured using Linear Bone Fill Measurements at 6 months and 12 months post-surgery 4. Gingival recession is measured using direct clinical measurements with a periodontal probe from the CEJ to the free gingival margin at baseline, 6 months, and 12 months 5. Post-operative pain is measured using the Visual Analog Scale (VAS) at immediately post-op (within 2-4 hours), Day 1 (24 hours post-surgery), Day 3 (72 hours post-surgery), Day 7 (1 week post-surgery), Day 14, and 1 month for delayed pain assessment | — |
Countries
Romania