Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

NCT02402296 | Completed Phase 4 Results

• 1 other identifier: Al-Azhar 1-2013
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Localized Aggressive Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0 and day 91 post therapy

Secondary Outcomes (3)

• Pocket Depth (PD)

  Day 0 and day 91 post therapy

• Gingival Index (GI)

  Day 0 and day 91 post therapy

• Matrix Metallo-proteinase (MMP-1&9)

  Day 0 and day 91 post therapy

Study Arms (2)

Group II (test group)

ACTIVE COMPARATOR

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.

Drug: β-1,3/1,6-D-glucan

Group I (control group)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

β-1,3/1,6-D-glucan 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.

Also known as: Imurril capsules 100mg

Group II (test group)

Placebo 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.

Also known as: Empty capsules filled with carbohydrates

Group I (control group)

Eligibility Criteria

• Age: 20 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Related Publications (1)

• • 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.

  BACKGROUND

MeSH Terms

Interventions

Carbohydrates

Limitations and Caveats

No limitations or caveats were reported throughout the study period.

Results Point of Contact

• Title: Professor Hala Helmi Hazzaa
• Organization: Al-Azhar University- Faculty of dental medicine (Girls branch)

hala.hazzaa@yahoo.com

00201014129297

Study Officials

• Hala H. Hazzaa, Professor

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Department of Oral Medicine, Periodontology, Diagnosis and Radiology

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 30, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 9, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-05