Phase 4
Completed N=30
Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Localized Aggressive Periodontitis
Source: ClinicalTrials.gov NCT02402296 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Assessment of Change in Clinical Attachment Level (CAL) — -14.07; -37.48 percentage of change
Summary
combining the non-surgical therapy with a well-tolerated substance that can stimulate protective immune responses like B-glucan, might effectively mount resolution pathways contributing to resolving of the chronic lesion observed in aggressive forms of periodontal disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Change in Clinical Attachment Level (CAL) |
-14.07; -37.48 | — |
| SECONDARY Pocket Depth (PD) |
-21.84; -37.01 | — |
| SECONDARY Gingival Index (GI) |
-0.87; -75.56 | — |
| SECONDARY Matrix Metallo-proteinase (MMP-1&9) |
-24.7; -29.5; -21.7; -36.7 | — |
Eligibility Criteria
Inclusion Criteria
- Except for periodontitis, patients were systemically healthy as evaluated by modified Cornell medical index.
- No more than two teeth other than first molars and incisors, with probing depth (PD) ≥ 5mm, bleeding on probing (BOP), and clinical attachment level (CAL) ≥ 5mm.
- Rapid rate of attachment loss and bone destruction.
- A radiographic examination revealing an evidence of moderate to severe vertical bone loss around permanent incisors and first molar teeth.
- Every patient should have at least 20 teeth excluding third (3rd) molars, and at least an extraction-indicated tooth for a dento-periodontal affection.
- Familial aggregation.
Exclusion Criteria
- Previous subgingival scaling and root planing, allergy to β-glucan, smoking, former smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic therapy in the previous 6 months and allergy to chlorhexidine.
Data sourced from ClinicalTrials.gov (NCT02402296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.