Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

• 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: Al-Azhar University
• Information provided by (Responsible Party): Hala Helmi Hazzaa, Al-Azhar University

Tracking Information

• First Submitted Date: March 6, 2015
• First Posted Date: March 30, 2015
• Results First Submitted Date: April 24, 2015
• Results First Posted Date: June 9, 2015
• Last Update Posted Date: June 9, 2015
• Study Start Date: January 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Localized Aggressive Periodontitis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2015): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 27 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02402296
• Other Study ID Numbers: Al-Azhar 1-2013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hala Helmi Hazzaa, Al-Azhar University
• Study Sponsor: Al-Azhar University
• Collaborators: Not Provided

Investigators

• 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