Comparative Evaluation of Selective Caries Removal Techniques Followed by SDF Application In Primary Molars - An In Vivo Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To clinically and radiographically evaluate the efficacy of caries removal using hand instruments,chemo-mechanical caries removing agent, and smart burs followed by SDF application and GIC restoration in deep carious primary molars.
研究概览
简要总结
Preoperative clinical and radiographic examinations will be done to ensure proper case selection. The involved tooth will be isolated with cotton rolls and a saliva ejector. The working time will be calculated from the beginning of caries excavation in all three groups, using a stopwatch. GROUP I (Caries removal using Hand Instruments followed by SDF application): The affected tooth will be visually inspected or probed, to determine the extent of decay. Then, the caries will be excavated using a sharp spoon excavator in gentle scraping motions to scoop out the soft, decayed dentin. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP II (Caries removal using chemo-mechanical caries removing agent followed by SDF application): The chemo-mechanical caries removing gel (Dengen Dental Carie Fix Caries
Removing Gel) will be applied to the lesion. After 30 seconds (as per the manufacturer’s instructions), the gel will be removed using a moistened cotton pellet, and softened carious dentin will be removed using a spoon excavator. If necessary, a second application can be performed in areas where the caries are hard, to soften the caries for easier removal. Once again, the gel will be removed using a moistened cotton pellet and the remaining caries will be excavated using a spoon excavator. Caries excavation will be considered complete when no caries can be detected with tactile method. GROUP III (Caries removal using polymer bur followed by SDF application): Caries will be excavated using polymer bur (SS White Smart Burs II). The polymer bur will be mounted on a low-speed contra-angled handpiece. Caries will be removed in a circular motion starting from the centre of the lesion towards the periphery. Caries removal will continue until polymer bur becomes dull after repeated contact with healthy dentin and becomes visibly abraded and blunt. Cutting will be done till no more softened dentin is present. Additional polymer burs can be used until caries are completely removed. Caries excavation will be evaluated using Ericson D et al. scale (1999). Caries excavation will be followed by the application of 38% Silver Diamine Fluoride solution (FAgamin). It will allow the removal of gross debris, allowing SDF to be in maximum contact with the affected dentin surface. Before the application of SDF, a protective coating of petroleum jelly will be applied to surrounding soft tissues to avoid their discoloration. One drop of SDF will be placed in a plastic dappen dish and will be applied to the excavated area with an applicator tip for 1 minute, using a gentle flow of compressed air until the liquid is dry. The remaining tooth structure will be restored with GC Gold Label Universal Restorative Cement. Time taken in caries excavation followed by SDF application during each procedure will be compared. Patient acceptance will be assessed using the Wong-Baker Faces Pain Scale which can easily be understood by
children as it consists of a series of faces depicting different levels of pain, ranging from a smiling face representing “no hurt†with a score of 0 and to a crying face indicating “hurts worst†with a score of 10. After the completion of the treatment, patients will be recalled after 1, 3, 6, and 9 months. Clinical and radiographic outcomes of the procedure will be recorded during each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children with written informed consent 2.Healthy children from 4 to 8 years of age 3.Cooperative child 4.Children with asymptomatic carious lesions in primary molars extending into the dentin (ICDAS score 4 OR 5) 5.Teeth that are restorable 6.No clinical evidence of pulpal degeneration (pain on percussion, history of swelling, sinus tract).
排除标准
- •1.Uncooperative children 2.Medically compromised patients 3.Teeth with a history of spontaneous pain or pulpal degeneration 4.Grossly decayed teeth 5.Teeth with radiographic signs of internal / external resorption or furcation involvement 6.Teeth near physiological exfoliation.
结局指标
主要结局
To clinically and radiographically evaluate the efficacy of caries removal using hand instruments,chemo-mechanical caries removing agent, and smart burs followed by SDF application and GIC restoration in deep carious primary molars.
时间窗: evaluation will be done immediately after procedure and at 1, 3, 6, and 9 months
次要结局
- time taken to complete procedure(immediately after procedure)
- pain perception by patient using Wong Baker FACES Pain Rating Scale(immediately after procedure)
- Score for Caries Excavation based on Ericson D et al. Criteria (1999)(at baseline)
- clinical evaluation : pain (on percussion), fistula, sinus opening & pathological mobility(at baseline, 1 month, 3 months, 6 months & 9 months)
- radiogarphic evaluation for pathologica root resorption, normal periodontal ligament space & absence of periapical and/or bifurcation radiolucency(at baseline, 1 month, 3 months, 6 months & 9 months)
研究者
Dr Meenu Bhola
Baba Farid University of health sciences, Faridkot
