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

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Localized Aggressive Periodontitis
• Interventions: Drug: β-1,3/1,6-D-glucan; Other: Placebo
• Enrollment: 30

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	15	15
Completed	15	15
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Group II (Test Group)	Group I (Control Group)	Total
Arm/Group 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. 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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		15	15	30
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	15 participants	30 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	15 100.0%	15 100.0%	30 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	15 participants	30 participants
		24.4 (2.37)	25 (1.94)	24.7 (2.11)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	15 participants	30 participants
	Female	8 53.3%	9 60.0%	17 56.7%
	Male	7 46.7%	6 40.0%	13 43.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Egypt	Number Analyzed	15 participants	15 participants	30 participants
		15	15	30

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	15	15
Mean (Standard Deviation); Unit of Measure: percentage of change
	-14.07 (12.29)	-37.48 (17.69)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	15	15
Mean (Standard Deviation); Unit of Measure: percentage of change
	-21.84 (17.12)	-37.01 (12.31)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	15	15
Mean (Standard Deviation); Unit of Measure: percentage of change
	-0.87 (0.83)	-75.56 (25.87)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	15	15
Mean (Standard Deviation); Unit of Measure: percentage of change
Percentage of change (Matrix metallo-proteinase 1)	-24.7 (4.2)	-29.5 (5.6)
Percentage of change (Matrix metallo-proteinase 9)	-21.7 (3.9)	-36.7 (9.6)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group I (Control Group)	Group II (Test Group)
Arm/Group Description	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.	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.
All-Cause Mortality
	Group I (Control Group)	Group II (Test Group)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Group I (Control Group)	Group II (Test Group)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Group I (Control Group)	Group II (Test Group)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/15 (0.00%)

Limitations and Caveats

No limitations or caveats were reported throughout the study period.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Professor Hala Helmi Hazzaa
• Organization: Al-Azhar University- Faculty of dental medicine (Girls branch)
• Phone: 00201014129297
• EMail: hala.hazzaa@yahoo.com

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.

• Responsible Party: Hala Helmi Hazzaa, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT02402296
• Other Study ID Numbers: Al-Azhar 1-2013
• First Submitted: March 6, 2015
• First Posted: March 30, 2015
• Results First Submitted: April 24, 2015
• Results First Posted: June 9, 2015
• Last Update Posted: June 9, 2015