Pulpectomies in Primary Molars Using Three Root Canal Filling Materials: A Double-blinded Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- clinical evaluation: Pain, Redness, Swelling/Abscess, Draining fistula and Mobility.
研究概览
简要总结
Pulpectomy is indicated in teeth that show evidence of chronic inflammation or necrosis in the radicular pulp, with or without periapical or furcation pathology. However, endodontic treatment of primary teeth is more challenging than that of their permanent counterparts; this is because of their anatomical complexities of their root canal systems and their proximity to the developing permanent tooth, coupled with the difficulty in behavior management in children. Presently, the most commonly used materials are: Zinc-Oxide Eugenol, Iodoform based pastes, and calcium hydroxide. In 1967, it was shown that ZOE set in a dense mass which resisted resorption and was very irritating to the periapical tissues in rats. In 1979, it was speculated that the resorption rate of ZOE and the root differed, resulting in small areas of ZOE paste possibly being retained and because of its hardness it might deflect the path of eruption of the succedaneous tooth. It also has limited antibacterial action, and cause necrosis of bone and cementum. Dominguez et al, reported that combining Iodoform and Calcium Hydroxide, it gave a success rate of 100%. But the main disadvantage was intra-radicular resorption of the material. A mixture of Calcium Hydroxide, ZOE, and Iodoform [ENDOFLAS] gave a success rate of 83% with good healing, having the resorption limited to the excess extruded extraradicularly, without washing intra-radicularly and resorptive capabilities and was said to be a good alternative to the traditionally used materials. There have been only limited human studies on this subject. The present study aims to evaluate the clinical and radiographic efficiency of three root filling materials – ZOE with Iodoform [RC Fill], Calcium hydroxide with Iodoform [VITAPEX], ZOE and Calcium hydroxide with Iodoform [ENDOFLAS], for a period of 3,6 and 12 months. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Non vital teeth
- •Teeth with mild or moderate mobility [grade I and II]
- •Teeth with deep carious lesion and exposures of pulp
- •Patients with the history of spontaneous pain
- •Teeth with no radiographically discernable internal or pathological external resorption
- •Teeth with inter-radicular and peri-radicular radiolucencies.
排除标准
- •Children with any medical history are excluded from the study.
结局指标
主要结局
clinical evaluation: Pain, Redness, Swelling/Abscess, Draining fistula and Mobility.
时间窗: Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.
Radiographic evaluation: Furcation radiolucency, Periapical radiolucency, Internal/External root resorption, Deviated eruption of succedaneous teeth, Excessive filling material and its resorption.
时间窗: Clinical and Radiographic evaluation of three root filling materials for a period of 3,6 and 12 months.
次要结局
- No Secondary Outcome measures applicable for this study.(Not applicable)