Localized Aggressive Periodontitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGβ-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.
OTHERPlacebo
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 27 Years
Healthy volunteers
No
Inclusion criteria
* Except for periodontitis, patients were systemically healthy as evaluated by modified Cornell medical index. * No more than two teeth other than first molars and incisors, with probing depth (PD) ≥ 5mm, bleeding on probing (BOP), and clinical attachment level (CAL) ≥ 5mm. * Rapid rate of attachment loss and bone destruction. * A radiographic examination revealing an evidence of moderate to severe vertical bone loss around permanent incisors and first molar teeth. * Every patient should have at least 20 teeth excluding third (3rd) molars, and at least an extraction-indicated tooth for a dento-periodontal affection. * Familial aggregation.
Exclusion criteria
* Previous subgingival scaling and root planing, allergy to β-glucan, smoking, former smoking, pregnancy, need of antibiotic coverage for routine dental therapy, antibiotic therapy in the previous 6 months and allergy to chlorhexidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Change in Clinical Attachment Level (CAL) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pocket Depth (PD) | 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) | Day 0 and day 91 post therapy | 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 |
| Matrix Metallo-proteinase (MMP-1&9) | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Group I (Control Group) | Group II (Test Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 1.94 | 24.4 years STANDARD_DEVIATION 2.37 | 24.7 years STANDARD_DEVIATION 2.11 |
| Region of Enrollment Egypt | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: Day 0 and day 91 post therapy
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Control Group) | Assessment of Change in Clinical Attachment Level (CAL) | -14.07 percentage of change | Standard Deviation 12.29 |
| Group II (Test Group) | Assessment of Change in Clinical Attachment Level (CAL) | -37.48 percentage of change | Standard Deviation 17.69 |
Secondary
Gingival Index (GI)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Control Group) | Gingival Index (GI) | -0.87 percentage of change | Standard Deviation 0.83 |
| Group II (Test Group) | Gingival Index (GI) | -75.56 percentage of change | Standard Deviation 25.87 |
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)
Time frame: Day 0 and day 91 post therapy
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I (Control Group) | Matrix Metallo-proteinase (MMP-1&9) | Percentage of change (Matrix metallo-proteinase 1) | -24.7 percentage of change | Standard Deviation 4.2 |
| Group I (Control Group) | Matrix Metallo-proteinase (MMP-1&9) | Percentage of change (Matrix metallo-proteinase 9) | -21.7 percentage of change | Standard Deviation 3.9 |
| Group II (Test Group) | Matrix Metallo-proteinase (MMP-1&9) | Percentage of change (Matrix metallo-proteinase 1) | -29.5 percentage of change | Standard Deviation 5.6 |
| Group II (Test Group) | Matrix Metallo-proteinase (MMP-1&9) | Percentage of change (Matrix metallo-proteinase 9) | -36.7 percentage of change | Standard Deviation 9.6 |
Secondary
Pocket Depth (PD)
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I (Control Group) | Pocket Depth (PD) | -21.84 percentage of change | Standard Deviation 17.12 |
| Group II (Test Group) | Pocket Depth (PD) | -37.01 percentage of change | Standard Deviation 12.31 |