Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Al-Azhar University

Status and phase: Completed; Phase 4

Conditions: Localized Aggressive Periodontitis

Treatments: Drug: β-1,3/1,6-D-glucan; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02402296

Al-Azhar 1-2013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 27 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Group II (test group)

Active Comparator group

Description:

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.

Treatment:

Drug: β-1,3/1,6-D-glucan

Group I (control group)

Placebo Comparator group

Description:

Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.

Treatment:

Other: Placebo