Radiographic and Clinical Assessment of Locally Delivered Camel Whey Protein Gel and Camel Whey Protein Nanoparticles Gel in Stage II Grade B Periodontitis: Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Mesiodistal (MD) and buccolingual (BL) bone defect width
研究概览
简要总结
Aim of the current study is to evaluate radiographic and clinical alterations following topical application of CWP gel and CWP nanoparticles gel in stage II grade B periodontitis patients.
详细描述
Periodontal disease is an oral inflammatory process that is typically initiated by bacterial infection stimulating the host response to produce various inflammatory mediators in high levels, which are also involved in the initiation and progression of periodontal disease.Such mediators generate a cascade reaction that eventually leads to the irreversible degradation of connective tissues and bone, with subsequent loss of periodontal attachment.
A new periodontitis classification scheme has been adopted, in which forms of the disease previously recognized as "chronic" or "aggressive" are now grouped under a single category ("periodontitis") and are further characterized based on a multi-dimensional staging and grading system. Staging is largely dependent upon the severity of disease at presentation as well as on the complexity of disease management, while grading provides supplemental information about biological features of the disease including a history-based analysis of the rate of periodontitis progression; assessment of the risk for further progression; analysis of possible poor outcomes of treatment; and assessment of the risk that the disease or its treatment may negatively affect the general health of the patient. periodontitis is classified using a system of staging and grading:
Staging reflects the severity and extent of disease based on tissue destruction:
- Stage I: Interdental CAL 1-2 mm, no tooth loss due to periodontitis, maximum probing depth ≤4 mm with horizontal bone loss mostly.
- Stage II: Interdental CAL 3-4mm, no tooth loss due to periodontitis, maximum probing depth ≤5mm with horizontal bone loss mostly.
- Stage III: Interdental CAL ≥5 mm, tooth loss due to periodontitis of ≤4 dents, maximum probing depth ≥ 6 mm and mostly associated with vertical bone loss.
- Stage IV: Interdental CAL ≥5 mm, tooth loss due to periodontitis of ≥5 dents and maximum probing depth ≥ 6 mm.
Grading of periodontitis refers to how quickly the disease is progressing.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients will be selected to be systemically free with stage II periodontitis
- •having 3-4 mm interdental clinical attachment loss (CAL) at ≥2 nonadjacent teeth
- •maximum probing depth ≤5 mm
排除标准
- •pregnant and lactating females
- •patients received any type of periodontal treatment in the past 6 months prior to examination
- •patients who used antibiotic or anti-inflammatory drugs or antioxidants within the 6 months preceding the beginning of the study
研究组 & 干预措施
placebo control group
After proper scaling and root planning, placebo gel will be applied topically to the affected sites.
干预措施: placebo gel (Drug)
CWP group
Topical application of CWP gel will be applied topically to the affected sites.
干预措施: CWP gel (Drug)
NCWP group
CWP nanoparticles gel will be applied topically to the affected sites.
干预措施: NCWP gel (Drug)
结局指标
主要结局
Mesiodistal (MD) and buccolingual (BL) bone defect width
时间窗: 6-months
The distance from the point AC to the alveolar crest (AC) will be considered as the MD width of the intraosseous defect. The BL width will be measured in the axial plane as the horizontal distance between the most coronal point for the buccal and lingual alveolar crest. A slice thickness of 0.2 mm will be used for CBCT analysis
Bone height:
时间窗: 6-months
This incorporated the measurement of the bone defect height from the cemento-enamel junction (CEJ) to the base of the defect BD, the level of the alveolar crest from CEJ to the alveolar crest (AC), the bone defect depth from AC to BD). A line perpendicular was drawn from the AC to the root surface, and the intersection point across the root surface was considered as AC. The distance from the point AC to the base of the defect (AC-BD) will be considered as the intraosseous defect depth.
次要结局
未报告次要终点
研究者
Walid Elamrousy
Assistant Professor of periodontology
Kafrelsheikh University
