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Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02402296
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Hala Helmi Hazzaa, Al-Azhar University

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.

Condition or disease Intervention/treatment Phase
Localized Aggressive Periodontitis Drug: β-1,3/1,6-D-glucan Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

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 Name: 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 Name: Empty capsules filled with carbohydrates




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)



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Ages Eligible for Study:   20 Years to 27 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402296


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

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Responsible Party: Hala Helmi Hazzaa, Assistant Professor in Department of Oral Medicine, Periodontology, Diagnosis and Radiology, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02402296    
Other Study ID Numbers: Al-Azhar 1-2013
First Posted: March 30, 2015    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms