An evaluation of nano-hydroxyapatite as a pulpotomy medicament in primary teeth.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- No clinical sign of pulp degeneration
研究概览
简要总结
Despite modern advances in the prevention ofdental caries and increased understanding of the importance of maintaining thenatural primary dentition, many teeth are still lost prematurely. Pulpotomy has remained an acceptable and mainstay treatment inpreserving the vitality of the primary tooth and prolonging its life till thepermanent successor erupts. The present study is a randomized, double blind, parallel group, active controlled trial to evaluate and compare theefficacy, both clinically and radiographically, of our new medicament Nano-hydroxyapatite and calcium hydroxide with 3% Nano-hydroxyapatite with the standard material MTA for pulpotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor 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
- •symptom-free deep carious mandibular primary molar tooth with vital pulp, sufï¬cient tooth structure for restoration with a stainless steel crown, no history of spontaneous pain, no clinical evidence of extensive pulp degeneration or periapical pathology,including tenderness to percussion, tooth mobility, abscess, ï¬stula, or swelling of the gingiva, no radiographic evidence of periapical pathosis or inter-radicular bone loss,internal resorption, pulp calcification, ankylosis, or pathologic external root resorption.
- •Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.
排除标准
- •Exclusion criteria included the presence of any systemic pathology any history of allergic reaction to latex, local anesthetics or to the constituents of the tested pulp dressing agents.
- •Clinical or radiographic sign or symptoms of pulp degeneration(i.e. spontaneous pain, excessive bleeding from the root canal,inter-radicular and/or periapical bone destruction).
结局指标
主要结局
No clinical sign of pulp degeneration
时间窗: Timepoints of measuring primary outcome is 3 months, 6 months, 9 months.
No radiographic sign of root and bone resorption
时间窗: Timepoints of measuring primary outcome is 3 months, 6 months, 9 months.
次要结局
- The restoration performance (partially or completely lost fillings, secondary caries at the margin, perforated or lost Stainless Steel crowns, severe Gingival inflammation)(Timepoints of measuring secondary outcome is 3 months,6 months, 9 months.)