NCT02402296

Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 20 Years – 27 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Localized Aggressive Periodontitis

Interventions

Type	Name	Description
DRUG	β-1,3/1,6-D-glucan	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.
OTHER	Placebo	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2015-03-30
• Last updated: 2015-06-09
• Results posted: 2015-06-09