Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

May 21, 2015 updated by: Hala Helmi Hazzaa, Al-Azhar University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 27 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 Names:
  • Imurril capsules 100mg
Placebo Comparator: Group I (control group)
Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) 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.
Other Names:
  • Empty capsules filled with carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Change in Clinical Attachment Level (CAL)
Time Frame: Day 0 and day 91 post therapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pocket Depth (PD)
Time Frame: Day 0 and day 91 post therapy
It is the distance from the base of the pocket till the gingival margin using Williams graduated probe
Day 0 and day 91 post therapy
Gingival Index (GI)
Time Frame: Day 0 and day 91 post therapy

Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing

  1. delayed bleeding on probing
  2. immediate bleeding on probing
  3. spontaneous bleeding
Day 0 and day 91 post therapy
Matrix Metallo-proteinase (MMP-1&9)
Time Frame: Day 0 and day 91 post therapy
Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)
Day 0 and day 91 post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Hala H. Hazzaa, Professor, Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Al-Azhar 1-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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