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Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

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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

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE March 30, 2015
Results First Submitted Date  ICMJE April 24, 2015
Results First Posted Date  ICMJE June 9, 2015
Last Update Posted Date June 9, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
  • 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
  • Gingival Index (GI) [ Time Frame: Day 0 and day 91 post therapy ]
    Using the values of the gingival index according to (Loe & Silness, 1963)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Official Title  ICMJE Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Localized Aggressive Periodontitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: β-1,3/1,6-D-glucan
  • 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.
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2015)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 27 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02402296
Other Study ID Numbers  ICMJE Al-Azhar 1-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hala Helmi Hazzaa, Al-Azhar University
Study Sponsor  ICMJE Al-Azhar University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala H. Hazzaa, Professor Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch)
PRS Account Al-Azhar University
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP