A Comparative Evaluation of Clinical Outcomes and Cone-Beam Computed Tomography Findings of Enamel Matrix Derivative and Amniotic Membrane in Regenerative Endodontic Treatment of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Radiographic assessment of root length by CBCT
研究概览
简要总结
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative and amniotic membrane in regenerative endodontic treatment of non-vital immature permanent anterior teeth
详细描述
To evaluate the clinical outcomes and cone-beam computed tomography findings of enamel matrix derivative in comparison to amniotic membrane and MTA as a conventional group in regenerative endodontic treatment of non-vital immature permanent anterior teeth
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
- Single (Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ranges between 7 and 12 years at the time of enrolment including both genders. •Provision of informed consent by one parent or legal guardian. •At least one immature permanent anterior tooth diagnosed with pulp necrosis with or without periapical lesions. •Restorable teeth. •Compliant patient/parent. •Radiologic evidence of open apices (Teeth are considered immature when a minimum of 1 mm apical foramen width is evident)
排除标准
- •Teeth with root fractures or split roots. •Presence of root resorptions. •Presence of periodontal pockets. •Developmental anomalies. •Presence of periapical radiolucency of more than 10 mm. •Tooth with class III mobility.
研究组 & 干预措施
Regenerative endodontic treatment using MTA
Regenerative endodontic treatment with conventional blood clot technique.
干预措施: Regenerative endodontic treatment with conventional blood clot technique. (Other)
Regenerative endodontic treatment using emdogain
regenerative endodontic treatment with emdogain
干预措施: regenerative endodontic treatment with emdogain. (Other)
Regenerative endodontic treatment using amniotic membrane
regenerative endodontic treatment with amniotic membrane
干预措施: regenerative endodontic treatment with amniotic membrane (Other)
结局指标
主要结局
Radiographic assessment of root length by CBCT
时间窗: Baseline (immediately post-operative), an 12 months post-operative.
For all cases, CBCT was taken at a setting of 3-7 mA and 120 kVp and an exposure time of 9 s. Each scan was taken over 360º with a 0.3 mm voxel size. The root length was measured using the CBCT ruler to draw a line from the center point of the line connecting CEJ to the most apical point in the center of the root apex (proximally and facially). The percentage of increase in root length was calculated using this formula: (12 months value - preoperative value )/Preoperative value X 100%
Radiographic assessment of diameter of apical foramen by CBCT
时间窗: Baseline(immediately post-operative), and 12 months post-operative.
Diameter of the apical foramen was measured using the CBCT ruler at the most apical points buccolingually at the sagittal (proximal) view of CBCT. It was also measured at the most apical points mesiodistally at the coronal (facial) view of CBCT. The percentage reduction of the apical diameter was calculated using this formula: ( preoperative value - 12-month value ) /Preoperative value \*100%
Radiographic assessment of root area by CBCT
时间窗: Baseline (immediately post-operative), and 12 months post-operative.
Radiographic root area (RRA) was measured using a method described by Flake et al using the polygon selection tool of CBCT. Below a straight line marking the CEJ, the root area was outlined from the surrounding periodontal environment. Then, the pulp space area was measured by the same method using the polygon tool by tracing the reference points surrounding the pulp space. Finally, RRA was calculated by subtraction of the pulp space area from the outer root area. These measurements were made at proximal and facial views of CBCT . The percentage increase in RRA was calculated using this formula: ( 12-month value - preoperative value )/Preoperative value X 100 %
Radiographic assessment of size of periapical lesion by CBCT
时间窗: Baseline (Immediately post-operative), and 12 months post-operative.
Lesion size was measured by tracing the periphery of the lesion using the polygon tool of the CBCT from proximal and facial views of the CBCT. A closed polygon tool was used to delimit the border of the lesion to measure the area of the periapical lesion in (mm2).The percentage reduction of lesion size was calculated as follows: ( preoperative value - 12-month value ) /Preoperative value X 100 %
次要结局
- Clinical assessment of presence/ absence of pain(Baseline, 3 months, 6 months, and 12 months post operative.)
- Clinical assessment of presence/ absence of mobility of teeth(Baseline, 3 months, 6 months, and 12 months post operative.)
- Clinical assessment of presence/ absence of associated sinus tract or swelling.(Baseline, 3 months, 6 months, and 12 months post operative.)
- Clinical assessment of presence/ absence of tenderness to palpation of adjacent soft tissues.(Baseline, 3 months, 6 months, and 12 months post operative.)
- Clinical assessment of presence/ absence of tenderness to percussion(Baseline, 3 months, 6 months, and 12 months post operative.)
研究者
Abrar Hamed Habib Yousef
Assistant Lecturer
Al-Azhar University