Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

NCT ID: NCT02402296

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-08-31

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.

Conditions

Localized Aggressive Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group II (test group)

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.

Group Type: ACTIVE_COMPARATOR

β-1,3/1,6-D-glucan

Intervention Type: DRUG

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.

Group I (control group)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Imurril capsules 100mg; Empty capsules filled with carbohydrates

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 27 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Hala Helmi Hazzaa

Assistant Professor in Department of Oral Medicine, Periodontology, Diagnosis and Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala H. Hazzaa, Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

References

• 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.

Reference Type: BACKGROUND

Other Identifiers

Al-Azhar 1-2013

Identifier Type: -

Identifier Source: org_study_id