A Randomized Controlled Trial to evaluate the efficacy of chitosan nanoparticle as a vehicle in lesion sterilisation and tissue repair(LSTR) in primary molars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Publication in PubMed/Scopus/Web of Science
研究概览
简要总结
This randomized controlled trial aims to evaluate the clinical and radiographic efficacy of chitosan nanoparticles as a vehicle for triple antibiotic paste in lesion sterilisation and tissue repair (LSTR) of primary molars in children aged 6–12 years. Eighty-two subjects will be divided into two equal groups: Group A (control) receiving triple antibiotic paste with propylene glycol, and Group B (intervention) receiving triple antibiotic paste with chitosan nanoparticle gel. Chitosan, known for its antimicrobial properties and enhanced drug delivery potential in nanoparticle form, may improve the effectiveness of LSTR. Follow-up assessments will be conducted at 1, 3, and 6 months post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical features 1.Children aged: 6- 12 years
- •Children with deep caries approximating pulp in primary molars.
- •Presence of gingival abscesses, fistula opening
- •Tooth showing one or more signs and symptoms such as pain, tender to percussion, mobility (grade I, II)
- •Pulpotomized tooth failure Radiographical features
- •Furcation, or periapical radiolucency
- •Evidence of pathologic external or internal root resorption with atleast two- thirds of the root
- •Coronal – deep carious lesion involving or approximating pulp
- •discontinuity of lamina dura.
排除标准
- •Clinical features
- •Non restorable tooth
- •Patients with medical problems, systemic diseases or drug allergy
- •Special children with a physical or emotional alteration
- •Caries in primary teeth exhibiting pre-shedding mobility or nearing exfoliation Radiographical features
- •Evidence of excessive internal or external root resorption involving more than half of the root
- •Perforated pulpal floor
- •excessive bone loss in furcation area involving underlying tooth germ.
结局指标
主要结局
Publication in PubMed/Scopus/Web of Science
时间窗: 1. Sample collection/ testing of samples: 1 year | 2. Follow up: 0 month,3rd month,6th month | 3. Result compilation & Statistical Analysis: 16th month | 4. Manuscript Completion: 17th month | 5. Publication process start: 18th month
• Patent
时间窗: 1. Sample collection/ testing of samples: 1 year | 2. Follow up: 0 month,3rd month,6th month | 3. Result compilation & Statistical Analysis: 16th month | 4. Manuscript Completion: 17th month | 5. Publication process start: 18th month
• Start-up Entrepreneurship potential
时间窗: 1. Sample collection/ testing of samples: 1 year | 2. Follow up: 0 month,3rd month,6th month | 3. Result compilation & Statistical Analysis: 16th month | 4. Manuscript Completion: 17th month | 5. Publication process start: 18th month
• Preliminary study for Extra-mural Grant
时间窗: 1. Sample collection/ testing of samples: 1 year | 2. Follow up: 0 month,3rd month,6th month | 3. Result compilation & Statistical Analysis: 16th month | 4. Manuscript Completion: 17th month | 5. Publication process start: 18th month
次要结局
未报告次要终点
研究者
DR SREELAKSHMI JAYALAL
Santosh Dental College Santosh Deemed to be University