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
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Condition or disease | Intervention/treatment | Phase |
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Localized Aggressive Periodontitis | Drug: β-1,3/1,6-D-glucan Other: Placebo | Phase 4 |
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 (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 |
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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.
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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.
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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 |
- 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
- 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
- delayed bleeding on probing
- immediate bleeding on probing
- 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)

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

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
Principal Investigator: | Hala H. Hazzaa, Professor | Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch) |
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 |
Periodontitis Aggressive Periodontitis Aggression Periodontal Diseases |
Mouth Diseases Stomatognathic Diseases Behavioral Symptoms |