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Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Primary Purpose

Localized Aggressive Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
β-1,3/1,6-D-glucan
Placebo
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Localized Aggressive Periodontitis

Eligibility Criteria

20 Years - 27 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Group II (test group)

    Group I (control group)

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Pocket Depth (PD)
    It is the distance from the base of the pocket till the gingival margin using Williams graduated probe
    Gingival Index (GI)
    Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing delayed bleeding on probing immediate bleeding on probing spontaneous bleeding
    Matrix Metallo-proteinase (MMP-1&9)
    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)

    Full Information

    First Posted
    March 6, 2015
    Last Updated
    May 21, 2015
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02402296
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Localized Aggressive Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group II (test group)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group I (control group)
    Arm Type
    Placebo Comparator
    Arm Description
    Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
    Intervention Type
    Drug
    Intervention Name(s)
    β-1,3/1,6-D-glucan
    Other Intervention Name(s)
    Imurril capsules 100mg
    Intervention Description
    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
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Empty capsules filled with carbohydrates
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Assessment of Change in Clinical Attachment Level (CAL)
    Description
    It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe
    Time Frame
    Day 0 and day 91 post therapy
    Secondary Outcome Measure Information:
    Title
    Pocket Depth (PD)
    Description
    It is the distance from the base of the pocket till the gingival margin using Williams graduated probe
    Time Frame
    Day 0 and day 91 post therapy
    Title
    Gingival Index (GI)
    Description
    Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing delayed bleeding on probing immediate bleeding on probing spontaneous bleeding
    Time Frame
    Day 0 and day 91 post therapy
    Title
    Matrix Metallo-proteinase (MMP-1&9)
    Description
    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)
    Time Frame
    Day 0 and day 91 post therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    27 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hala H. Hazzaa, Professor
    Organizational Affiliation
    Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    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.
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    Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

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