Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Study Overview
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Brief Summary
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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.

Detailed Description
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Aim: To investigate the efficacy of β-glucan supplementation to non-surgical periodontal therapy in localized aggressive periodontitis (LAP) patients. Method: 30 subjects were randomly and equally assigned to receive scaling and root planing; either with placebo pills (Group I) or β-glucan (100 mg/once a day) (Group II), for 40 days. Subjects were clinically monitored on day 0 and day 91. Gingival samples were harvested from hopeless teeth sites to be investigated histologically and immunohistochemically using matrix metalloproteinase (MMP)-1 and 9 antibodies form each patient; at the same time intervals.

Official Title
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Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial

Conditions
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Localized Aggressive Periodontitis

Intervention / Treatment
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* Drug: β-1,3/1,6-D-glucan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group II (test group)<br>Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing. | Drug: β-1,3/1,6-D-glucan<br>* 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.<br>* Other names: Imurril capsules 100mg;|
| Placebo Comparator: Group I (control group)<br>Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. | Other: Placebo<br>* 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.<br>* Other names: Empty capsules filled with carbohydrates;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Change in Clinical Attachment Level (CAL) | It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe | Day 0 and day 91 post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket Depth (PD) | It is the distance from the base of the pocket till the gingival margin using Williams graduated probe | Day 0 and day 91 post therapy | 
| Gingival Index (GI) | Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing delayed bleeding on probing immediate bleeding on probing spontaneous bleeding | Day 0 and day 91 post therapy | 
| Matrix Metallo-proteinase (MMP-1&9) | Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes) | Day 0 and day 91 post therapy |