Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 主要终点
- Clinical success in term of the absence of post-operative pain
研究概览
简要总结
Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.
详细描述
Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.
Calcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.
- •Extension of carious lesion such that complete caries removal would risk pulp exposure.
- •History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.
- •Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.
排除标准
- •• History of spontaneous sharp, penetrating pain, or tenderness on percussion
- •Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.
- •Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
- •Pulp exposure during caries removal.
- •Parental refusal for participation.
研究组 & 干预措施
indirect pulp treatment with NeoPUTTY MTA
干预措施: NeoPUTTY MTA (Drug)
indirect pulp treatment with calcium hydroxide
干预措施: calcium hydroxide (Drug)
结局指标
主要结局
Clinical success in term of the absence of post-operative pain
时间窗: one year
Visual analog scale
Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula
时间窗: one year
Visual and clinical examinations
次要结局
- Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes(one year)
研究者
marwa aly fouad elchaghaby
Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.
Cairo University