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
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
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.
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)
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)|