Clinical trial NCT02402296: Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Official title: Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Localized Aggressive Periodontitis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Assessment of Change in Clinical Attachment Level (CAL)
timeFrame: Day 0 and day 91 post therapy
Secondary outcomes:
measure: Pocket Depth (PD)
timeFrame: Day 0 and day 91 post therapy
measure: Gingival Index (GI)
timeFrame: Day 0 and day 91 post therapy
measure: Matrix Metallo-proteinase (MMP-1&9)
timeFrame: Day 0 and day 91 post therapy
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
name: Hala H. Hazzaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: • Prakasam A; Elavarasu SS; Natarajan RK. Antibiotics in the management of aggressive periodontitis. J Pharm Bioallied Sci. 2012; 4 (Suppl 2): S252-5. • Aurer A; Recent Advances in periodontology. Med Sci 2012; 38: 49-59. • Acar NN; Noyan Ü; Kuru L;Kadir T; Kuru B. Adjunctive systemic use of beta-glucan in the nonsurgical treatment of chronic periodontitis. Pathogenesis and treatment of periodontitis 2012; 11: 167-82. • Stashenko P; Wang CY; Riley E; Wu Y; Ostroff G; Niederman R. Reduction of infection-stimulated periapical bone resorption by the biological response modifier PGG Glucan. J Dent Res 1995; 74 (1):323-30. • Chaple CC; Srivastrava M; Hunter N; Failure of macrophage activation in destructive periodontal disease. J Pathol 1988; 186: pp.281-286.