Efficacy of β-glucan in Treatment of Localized Aggressive Periodontitis: A Short Term Double-blinded, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Assessment of Change in Clinical Attachment Level (CAL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: β-1,3/1,6-D-glucan (Drug)
Group I (control group)
Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.
干预措施: Placebo (Other)
结局指标
主要结局
Assessment of Change in Clinical Attachment Level (CAL)
时间窗: 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
次要结局
- Matrix Metallo-proteinase (MMP-1&9)(Day 0 and day 91 post therapy)
- Pocket Depth (PD)(Day 0 and day 91 post therapy)
- Gingival Index (GI)(Day 0 and day 91 post therapy)
研究者
Hala Helmi Hazzaa
Assistant Professor in Department of Oral Medicine, Periodontology, Diagnosis and Radiology
Al-Azhar University