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
About this trial
This is an interventional treatment trial for Localized Aggressive Periodontitis
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.
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
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.
Results Reference
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Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
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