Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
研究概览
简要总结
The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.
详细描述
Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of pulpal necrosis with apical periodontitis
- •patients 7-60 years of age
- •maxillary or mandibular restorable single rooted immature permanent tooth with open apices
- •acceptance of treatment plan with revascularization procedure
- •healthy patient (ASA Class I or II physical status) with no systemic health problems
排除标准
- •non-restorable teeth
- •patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
- •child subjects unable to give assent
研究组 & 干预措施
Group A
Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole
干预措施: Double Antibiotic Paste (Drug)
Group B
Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline
干预措施: Triple Antibiotic Paste (Drug)
Group C
Group C - Mineral trioxide aggregate: used as an apical barrier
干预措施: Mineral Trioxide Aggregate (Drug)
结局指标
主要结局
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
时间窗: 3 measurements over 6 months
1. st radiograph taken at 1 month post-procedure completion 2. nd radiograph taken at 3 month post-procedure completion 3. rd radiograph taken at 6 month post-procedure completion
次要结局
- The secondary outcomes will be lack of clinical symptoms and crown staining.(assessed over the 6 month study period)
研究者
Kenneth Hargreaves
Chair, Department of Endodontics
The University of Texas Health Science Center at San Antonio