Strategic management of selectively resorbed roots in primary molars: A prospective cohort study evaluating combined Lesion Sterilization-Tissue Repair and Pulpectomy in 5- to 8-year-old children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical –Pain, tenderness, swelling,mobility, sinus formation
研究概览
简要总结
Pathological root resorption is a sequala of pulp necrosis, which in case of multi-rooted teeth, may lead to selective resorption of a single root, while the other root(s) remains intact. This predisposes to premature tooth extraction, which in children can compromise space management, mastication and speech. A systematic review by Coll et al(2020) suggests performing lesion-sterilisation-tissue-repair(LSTR) therapy when root resorption is greater than one-third and expected duration of survival is less than 12 months, while pulpectomy is recommended for teeth with minimal to no resorption. Pathological root resorption is a sequala of pulp necrosis, which in case of multi-rooted teeth, may lead to selective resorption of a single root, while the other root(s) remains intact. In this study, involving deciduous molars with selective root resorption, pulpectomy and LSTR will be performed in the intact and resorbed root(s), respectively. Irrigation will be done using 2.5% Sodium hypochlorite and normal saline. The intact root(s) will be obturated using Endoflass material, while LSTR will be performed using di-antibiotic paste in the resorbed root. Following the single-visit procedure, all teeth will be restored with a stainless-steel crown and recalled after 3,6 and 12 months for clinical and radiographic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Spontaneous pain or tenderness to percussion ii.
- •Deep carious lesion with or without pulp exposure iii.
- •Presence of chronic apical abscess or sinus tract iv.
- •Clinically restorable (at least 1 intact wall in the coronal structure).
排除标准
- •Children with any medical, physical, cognitive or intellectual condition/abnormality ii.
- •Clinically non-restorable iii.
- •Physiologic or pathologic root resorption of all roots greater than 1/3rd of original length iv.
- •Excessive mobility beyond grade 2, as per the classification by Ramfjord(1967).
- •Internal calcifications or root canal obliteration vi.
- •Excessive internal resorption (involving greater than half the radicular width) vii.
- •Perforation of the pulpal floor during caries excavation viii.
- •Presence of an underlying pathology (cyst/calcified lesion) ix.
- •Deviation of the successor tooth germ beyond 30°.
结局指标
主要结局
Clinical –Pain, tenderness, swelling,mobility, sinus formation
时间窗: 3,6,12 months
次要结局
- Radiographic-Size of Radiolucency, reduction in radiolucency, internal resorption(3,6, 12 months)
研究者
Dr Mugilan Ravi
All India Institute of Medical Sciences, Raipur