Trial Outcomes & Findings for Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis (NCT NCT02402296)
NCT ID: NCT02402296
Last Updated: 2015-06-09
Results Overview
It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe
COMPLETED
PHASE4
30 participants
Day 0 and day 91 post therapy
2015-06-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis
Baseline characteristics by cohort
| Measure |
Group II (Test Group)
n=15 Participants
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.
|
Group I (Control Group)
n=15 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 2.37 • n=5 Participants
|
25 years
STANDARD_DEVIATION 1.94 • n=7 Participants
|
24.7 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and day 91 post therapyPopulation: 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
It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe
Outcome measures
| Measure |
Group I (Control Group)
n=15 Participants
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.
|
Group II (Test Group)
n=15 Participants
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.
|
|---|---|---|
|
Assessment of Change in Clinical Attachment Level (CAL)
|
-14.07 percentage of change
Standard Deviation 12.29
|
-37.48 percentage of change
Standard Deviation 17.69
|
SECONDARY outcome
Timeframe: Day 0 and day 91 post therapyPopulation: 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
It is the distance from the base of the pocket till the gingival margin using Williams graduated probe
Outcome measures
| Measure |
Group I (Control Group)
n=15 Participants
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.
|
Group II (Test Group)
n=15 Participants
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.
|
|---|---|---|
|
Pocket Depth (PD)
|
-21.84 percentage of change
Standard Deviation 17.12
|
-37.01 percentage of change
Standard Deviation 12.31
|
SECONDARY outcome
Timeframe: Day 0 and day 91 post therapyPopulation: 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.
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
Outcome measures
| Measure |
Group I (Control Group)
n=15 Participants
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.
|
Group II (Test Group)
n=15 Participants
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.
|
|---|---|---|
|
Gingival Index (GI)
|
-0.87 percentage of change
Standard Deviation 0.83
|
-75.56 percentage of change
Standard Deviation 25.87
|
SECONDARY outcome
Timeframe: Day 0 and day 91 post therapyPopulation: 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.
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)
Outcome measures
| Measure |
Group I (Control Group)
n=15 Participants
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.
|
Group II (Test Group)
n=15 Participants
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.
|
|---|---|---|
|
Matrix Metallo-proteinase (MMP-1&9)
Percentage of change (Matrix metallo-proteinase 1)
|
-24.7 percentage of change
Standard Deviation 4.2
|
-29.5 percentage of change
Standard Deviation 5.6
|
|
Matrix Metallo-proteinase (MMP-1&9)
Percentage of change (Matrix metallo-proteinase 9)
|
-21.7 percentage of change
Standard Deviation 3.9
|
-36.7 percentage of change
Standard Deviation 9.6
|
Adverse Events
Group I (Control Group)
Group II (Test Group)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Hala Helmi Hazzaa
Al-Azhar University- Faculty of dental medicine (Girls branch)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place