Stage III Periodontitis
Conditions
Brief summary
Periodontitis is a chronic multifactorial inflammatory disorder affecting the periodontium, often implicated with microbial dysbiosis. Following the establishment of a proper diagnosis, the initial therapeutic phase within the recommended protocol must focus patient motivation and behavior alongside the comprehensive management of modifiable local and systemic risk factors. Although SRP effectively reduces microbial load, complete regeneration of periodontal tissues remains challenging due to limited healing potential and persistent inflammation. Various adjunctive therapies have been explored to enhance periodontal healing, including oxygen-based and platelet concentrate approaches. Topical oxygen therapy has recently gained attention for its antimicrobial and regenerative properties. Oxygen-releasing gels, such as those containing stabilized hydrogen peroxide, increase local oxygen tension, inhibit anaerobic pathogens, and promote angiogenesis and fibroblast proliferation, resulting in improved clinical parameters following SRP. Injectable platelet-rich fibrin (i-PRF), a second-generation autologous platelet concentrate, provides a sustained release of growth factors such as PDGF, VEGF, and TGF-β, enhancing soft tissue healing and bone regeneration. Clinical trials have demonstrated that i-PRF used with SRP significantly improves probing depth reduction, attachment gain, and bleeding scores compared with SRP alone. However, no studies have directly compared oxygen therapy and i-PRF as adjuncts to non-surgical periodontal therapy. Investigating these two bio stimulatory approaches could identify a minimally invasive, cost-effective strategy to optimize periodontal healing and regeneration.
Interventions
BIOLOGICALInjectable Platelet-Rich Fibrin (i-PRF
Autologous injectable platelet-rich fibrin prepared chairside from 10 mL patient venous blood collected in plain plastic tubes without anticoagulant. Blood centrifuged at 700 rpm (60g) for 3 minutes using fixed-angle centrifuge at room temperature. Supernatant liquid fraction (upper 4-5 mL, yellowish) collected via 3 mL syringe with 27G needle. Immediately injected subgingivally (1-2 mL per site) through custom acrylic stent notches targeting sites with CAL ≥4 mm and PPD ≥5 mm. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Contains PDGF-BB, TGF-β1, VEGF, IGF-1, and viable leukocytes for sustained regenerative effect over 7-10 days.
DRUGPeroxoborate Oxygen-Releasing Oral Gel
Stabilized peroxoborate/peroxide-based oxygen-releasing dental gel (5-10% active oxygen equivalent, neutral pH 6.8-7.2). Applied via 3 mL blunt-tip syringe (27G) through acrylic stent notches (1-2 mL per site) to fill CAL ≥4 mm, PPD ≥5 mm periodontal pockets completely. Provides continuous oxygen release (O2 + reactive oxygen species) for 24-48 hours, creating anaerobic microenvironment disruption, bacterial kill, and enhanced tissue oxygenation. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications). Excess gel expressed from pocket orifice confirms complete filling
OTHERSterile 0.9% Saline Solution
Pharmaceutical-grade sterile 0.9% sodium chloride irrigation solution (pH 5.0-7.0, preservative-free). Identical 3 mL syringe delivery through 27G needle and acrylic stent as active arms (1-2 mL per site). Volume/color matches i-PRF; injection technique mimics biologic viscosity. Applied at baseline + weeks 2, 4, 6, 8 (5 total applications) to maintain blinding. Provides sham subgingival irrigation without therapeutic effect, standardizing procedure across all arms
PROCEDUREScaling and Root Planing (SRP)
Full-mouth non-surgical periodontal debridement performed in 2 sessions (45-60 min each, 1-week interval). Supragingival/subgingival scaling using ultrasonic scaler (Cavitron, 30K Hz) + hand instruments (Gracey curettes 11/12, 13/14, universal 7/8). Root planning to remove cementum-embedded calculus and bacterial toxins from root surfaces. Sites with PPD ≥5 mm receive special attention. Local anesthesia (2% lidocaine 1:100K epi) as needed. Post-SRP oral hygiene instructions: modified Bass brushing technique (2x daily), interdental brushes/floss
DEVICECustom Acrylic Probing Sten
Individually fabricated acrylic stent (2-3 mm thick) from alginate impression of maxillary/mandibular study teeth. Vertical grooves/notches (2 mm deep) cut at mesio-buccal, mid-buccal, disto-buccal sites using #15C scalpel on stone cast. Trimmed/polished for patient comfort while maintaining reference points. Serves as fixed coronal landmark for UNC-15 probe insertion during CAL/PPD measurements at baseline, weeks 4, 8, 12. Ensures measurement reproducibility (±0.5 mm) across examiners/timepoints. Autoclaved between visits.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * Patients with PPD ≤5 mm and clinical attachment loss of 3-4 mm grade A; * Presence of 2 walled or 3 walled infra-bony defects posterior segments; * Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs. *
Exclusion criteria
* Patients requiring antibiotic prophylaxis before the periodontal examination; * Patients diagnosed with malocclusion at the site of the defect; * Patients with systemic disease and/or on drugs that contraindicate periodontal surgery; * Patients with a history of smoking and pan chewing;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | Baseline, Weeks 4, 8, 12 | Difference in CAL (mm) measured from custom acrylic stent reference point to base of periodontal pocket using UNC-15 periodontal probe at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) in sites with baseline CAL ≥5 mm. Primary endpoint: Week 12 CAL gain |
| Change in Probing Pocket Depth (PPD) | Baseline, Weeks 4, 8, 12 | Difference in PPD (mm) from gingival margin to pocket base via UNC-15 probe through stent notches. Primary endpoint: Week 12 PPD reduction. |
| Bleeding on Probing (BOP) | Baseline, Weeks 4, 8, 12 | Percentage of sites exhibiting bleeding within 30 seconds of gentle probing (presence/absence recorded). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Fill | Baseline to Week 12 | Vertical bone level change (mm) measured on standardized digital periapical radiographs using image analysis software (vertical byte-wing technique, paralleling technique) |
| Gingival Index (GI) | Baseline, Weeks 4, 8, 12 | Gingival inflammation scored at 6 sites per tooth using Löe \& Silness Gingival Index (0 = normal; 1 = mild inflammation; 2 = moderate inflammation; 3 = severe inflammation). Mean GI score per patient calculated from study sites (CAL ≥5 mm). Quantitative (Mean GI score 0-3) |
Countries
Egypt
Outcome results
None listed