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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group II (test group) | Active Comparator | 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. |
|
| Group I (control group) | Placebo Comparator | Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| β-1,3/1,6-D-glucan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 and day 91 post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Depth (PD) | It is the distance from the base of the pocket till the gingival margin using Williams graduated probe | Day 0 and day 91 post therapy |
| Gingival Index (GI) | Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hala H. Hazzaa, Professor | Al-Azhar University, Faculty of Dental and Oral Medicine (Girls Branch) | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | • 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Control Group) | Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements | Posted | Mean | Standard Deviation | percentage of change | Day 0 and day 91 post therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Control Group) | Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. 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. |
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No limitations or caveats were reported throughout the study period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Hala Helmi Hazzaa | Al-Azhar University- Faculty of dental medicine (Girls branch) | 00201014129297 | hala.hazzaa@yahoo.com |
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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|
| Placebo | Other | 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. |
|
|
| Day 0 and day 91 post therapy |
| 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) | Day 0 and day 91 post therapy |
| BG001 | Group I (Control Group) | Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
|
|
| Secondary | Pocket Depth (PD) | It is the distance from the base of the pocket till the gingival margin using Williams graduated probe | A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings | Posted | Mean | Standard Deviation | percentage of change | Day 0 and day 91 post therapy |
|
|
|
| Secondary | Gingival Index (GI) | Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing
| A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings. | Posted | Mean | Standard Deviation | percentage of change | Day 0 and day 91 post therapy |
|
|
|
| Secondary | 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) | A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings. | Posted | Mean | Standard Deviation | percentage of change | Day 0 and day 91 post therapy |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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. 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. | 0 | 15 | 0 | 15 |
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