Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Al-Azhar University30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Localized Aggressive Periodontitis

Interventions

β-1,3/1,6-D-glucanDRUG

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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 27 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Day 0 and day 91 post therapy

Secondary Outcomes

Pocket Depth (PD)

It is the distance from the base of the pocket till the gingival margin using Williams graduated probe

Time frame: 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 1. delayed bleeding on probing 2. immediate bleeding on probing 3. spontaneous bleeding

Time frame: 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)

Time frame: Day 0 and day 91 post therapy

Data from ClinicalTrials.gov

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