Host Modulatory Effects of β-glucan on Localized Aggressive Periodontitis

Phase 4

Completed

• Conditions: Localized Aggressive Periodontitis
• Interventions: Other: Placebo; Drug: β-1,3/1,6-D-glucan

• Registration Number: NCT02402296
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-06
• Study Completion: 2014-08
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Results First Submitted: 2015-04-24
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Results First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (control group)	Placebo	Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
Group II (test group)	β-1,3/1,6-D-glucan	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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