Comparison of Three Techniques in Bioceramic Apexification Procedure for Necrotic Immature Incisors: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical evaluation
研究概览
简要总结
The goal of this randomized clinical trial is to find the most effective Bioceramic-based apexification procedures in children with immature necrotic maxillary incisors. The main questions they aims to answer are:
- What is the best Bioceramic apexification technique regarding the post-operative pain and the periapical healing ?
- What is the best Bioceramic apexification technique regarding the bioceramics extrusion and the required time ? Participants will under gone Bioceramic apexification procedures which root canal preparing, disinfecting, filling, and restoring. Then, the patient will asked to come to follow-up appointments for clinical and radiological evaluations If there is a comparison group: Researchers will compare Bioceramic Putty Apical Plugs, Single Cone Gutta-percha with Bioceramic Sealer, and Combination of Bioceramic putty and sealer technique to find the best effective technique.
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
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with one or more maxillary incisors with an open apex root (defined as root which root canal size equal or larger than #80 K-file) and presented with pulp necrosis and radiographic evidence of chronic apical periodontitis and periapical radiolucency greater than 3 mm.
排除标准
- •Children with systemic diseases that compromised their general immune status.
- •Uncooperative (definitely negative on the Frankl's behavioral scale).
- •unrestorable incisors.
研究组 & 干预措施
Bioceramic Putty Apical Plugs
The Bioceramic Putty will be inserted in the apical 4 mm of the canal using the modified cannula and adapted to the canal walls with a hand plugger.
干预措施: Bioceramic Putty Apical Plugs (Other)
Single Cone Gutta-percha with Bioceramic Sealer
A large sized (#80 - #120, and a taper of 2%) gutta-percha cone (GC) will be inserted, measuring according to the width of the canal, to the working length, then the immature canal will be gently filled with Bioceramic sealer and the GC.
干预措施: Single Cone Gutta-percha with Bioceramic Sealer (Other)
Combination of Bioceramic Putty and Sealer
The immature canal will be gently filled with Bioceramic sealer and then 3 to 5 small balls of BP will be inserted into the canal orifice and gently plugged with hand pluggers.
干预措施: Combination of Bioceramic Putty and Sealer (Other)
结局指标
主要结局
Clinical evaluation
时间窗: 12 months
Patients of both groups will be recalled after 1, 3, 7, and 14 days of treatment and during radiographical assessment periods (3, 6 and 12 months), where they will be asked to rate their pain on the Wong-Baker Faces Scale, where children will set their pain levels by choosing a face; 0 = No Hurt, 1 = Hurts little bit, 2 = hurts Little more 3 = Hurts even more, 4 = Hurts whole lot, and 5 = Hurts worst. Moreover, the presence of fistula, swelling, and movement will be recorded.
Radiographical assessment
时间窗: 12 months
After coronal restoration is completed a control x-ray will be taken. The periapical status will be assessed at the time of obturation-restoration, 3, 6, and 12 months following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system: (1) normal periapical structures (The best); (2) small changes in bone structure; (3) changes in bone structure with some mineral loss; (4) periodontitis with well-defined radiolucent area; (5) severe periodontitis with exacerbating features (The worst). The teeth will be evaluated according to healed, healing or unsuccessful as a primary radiographical outcome.
次要结局
未报告次要终点