Regenerative endodontic procedures for treatment of necrotic mature teeth with periapical lesions - a randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome is obtained by evaluating the clinical and radiographic outcomes
研究概览
简要总结
This study is a randomized ,double blind, parallel group,controlled trial
The aim of the present study is to assess the radiographic healing and the possibility of regaining pulp sensibility in mature permanent teeth with necrotic pulps that were treated using two REPs
REP with blood clot and REP with collagen as scaffold
The primary objective of this study is to compare and evaluate the efficacy of REP using Collagen and blood clots as scaffolds for the treatment of mature permanent teeth with necrotic pulp
The secondary aim is to assess the factors influencing the clinical outcomes of REP in mature permanent teeth with necrotic pulps
Age of the patient
Apical diameter enlargement
Disinfection protocols
The primary outcome of this study is the success rate of REP 12 months postoperatively which will be obtained by evaluating the clinical and radiographic outcomes
The secondary outcomes include the subjective response from the patient to thermal and electric stimuli which reflects the responsiveness of regenerative pulpal sensory neurons
Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346
Arslan H, Ahmed HMA, Şahin Y, Doğanay Yıldız E, Gündoğdu EC, Güven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Nonvital single rooted maxillary anterior tooth with a mature root and a periapical lesion with a periapical index score equal to or more than 3 according to the classification of orstavik et al 1986 Radiologic confirmation of a single rooted necrotic tooth with a single root canal.
排除标准
- •Teeth with severe coronal defects that require post and core as final restoration Non-restorable teeth Presence of other pathological root resorption Teeth with previous root canal treatment Presence of periodontitis Pregnant or lactating females A history of systemic diseases or any allergies.
结局指标
主要结局
The primary outcome is obtained by evaluating the clinical and radiographic outcomes
时间窗: Baseline 3month 6month 12month
Success
时间窗: Baseline 3month 6month 12month
After REP
时间窗: Baseline 3month 6month 12month
the tooth is asymptomatic absence of percussion pain sinus or fistula
时间窗: Baseline 3month 6month 12month
The radiographic examination demonstrates the absence or reduced apical shadow
时间窗: Baseline 3month 6month 12month
Failure
时间窗: Baseline 3month 6month 12month
the tooth is symptomatic with symptoms of apical infection such as pain and fistula
时间窗: Baseline 3month 6month 12month
The radiographic examination demonstrates a new onset apical shadow or an enlarged apical shadow
时间窗: Baseline 3month 6month 12month
次要结局
- The secondary outcomes include the subjective response from the patient to thermal & electric(stimuli, which reflects the responsiveness of regenerative pulpal sensory neurons.)
研究者
M S REZVANA BEGUM
Rajah muthiah dental college and hospital