A Phase 1/2 interventional study of Injectable Platelet-Rich Fibrin (i-PRF and Peroxoborate Oxygen-Releasing Oral Gel in Stage III Periodontitis, sponsored by Assiut University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Assiut University · Phase 1/2, Interventional, and Treatment
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 (1). 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 (2).
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 (3).
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 24 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Biological: Injectable Platelet-Rich Fibrin (i-PRF · Other: Sterile 0.9% Saline Solution · Procedure: Scaling and Root Planing (SRP) · Device: Custom Acrylic Probing Sten
Drug: Peroxoborate Oxygen-Releasing Oral Gel · Other: Sterile 0.9% Saline Solution · Procedure: Scaling and Root Planing (SRP) · Device: Custom Acrylic Probing Sten
Other: Sterile 0.9% Saline Solution · Procedure: Scaling and Root Planing (SRP) · Device: Custom Acrylic Probing Sten
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.
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
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
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
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.
Change in Clinical Attachment Level (CAL)
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
Time frame: Baseline, Weeks 4, 8, 12
Change in Probing Pocket Depth (PPD)
Difference in PPD (mm) from gingival margin to pocket base via UNC-15 probe through stent notches. Primary endpoint: Week 12 PPD reduction.
Time frame: Baseline, Weeks 4, 8, 12
Bleeding on Probing (BOP)
Percentage of sites exhibiting bleeding within 30 seconds of gentle probing (presence/absence recorded).
Time frame: Baseline, Weeks 4, 8, 12
Radiographic Bone Fill
Vertical bone level change (mm) measured on standardized digital periapical radiographs using image analysis software (vertical byte-wing technique, paralleling technique)
Time frame: Baseline to Week 12
Gingival Index (GI)
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)
Time frame: Baseline, Weeks 4, 8, 12
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Assiut University