A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Pain intensity measures
研究概览
简要总结
This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.
详细描述
the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
For the allocation concealment mechanism, each of 66 papers (each paper was eight folded) numbered from 1 to 66 were, individually packed, in opaque envelopes. Each participant picked an envelope at the beginning of the second visit. The number in the envelope determined which procedure was to be performed for the patient. The partner was to decide the procedure for the operator according to that number.
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.
排除标准
- •History of allergy to any of the antibiotics in the tri-mix used in the study
- •Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
- •Psychological disturbance
- •External / internal root resorption or cystic lesion.
研究组 & 干预措施
Revascularization
Blood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
干预措施: revascularization (Procedure)
Apexfication
Apexification using grey MTA apically compacted without mechanical preparation.
干预措施: Apexification (Procedure)
结局指标
主要结局
Pain intensity measures
时间窗: 2 days
self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.
次要结局
- Decrease of apical diameter:(baseline and 9 months)
- Amount of radiographic increase in root length:(baseline and 9 months)
- Resolution of periapical pathosis(9 months)
- Amount of radiographic increase in the root dentinal wall thickness:(baseline and 9 months)
研究者
Enas Ebrahim Sayed
Dentist at ministry of health
Cairo University