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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
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I (Control Group) Group II (Test Group)
Hide 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
Arm/Group Title Group II (Test Group) Group I (Control Group) Total
Hide 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
Hide 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
1.Primary Outcome
Title Assessment of Change in Clinical Attachment Level (CAL)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide Description

Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing

  1. delayed bleeding on probing
  2. immediate bleeding on probing
  3. spontaneous bleeding
Time Frame Day 0 and day 91 post therapy
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group I (Control Group) Group II (Test Group)
Hide 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   --/--   --/-- 
Hide 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%) 
Hide 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%) 
No limitations or caveats were reported throughout the study period.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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.
Layout table for additonal information
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