A randomized equivalence clinical trial to evaluate the efficacy of an innovative, non-obturation endodontic treatment protocol “SealBio†for mature, permanent non-vital teeth as compared to conventional endodontic treatment with root canal obturation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Complete control and resolution of clinical signs
研究概览
简要总结
To evaluate and compare the healing response following novel, non-obturation endodontic treatment and the conventional endodontic treatment protocol by clinical and radiographic evaluation with pre and post treatment digital intra-oral X-ray and Cone Beam Computed Tomography (CBCT).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
192 cases of at least 2 periapically infected teeth will be included in the study (Sample calculation shown in Materials and methods). Ethical clearance and informed consent of the patient will be taken. Inclusion and exclusion criteria will be laid down and followed. One of the affected teeth will be treated by conventional endodontic procedure of cleaning, shaping, disinfection, obturation and coronal seal. The other tooth will be treated by the novel treatment protocol. Pretreatment digital intraoral periapical X rays and CBCT will be taken. The cases will be followed up at 3, 6 months, 1, 1 ½ and 2 years and evaluated clinically and radiographically. Post treatment CBCT will be taken only at 6-months interval. The data will be analyzed and healing response will be compared in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Cases presenting with clinical or radiographic signs and symptoms of periapical pathologies, irrespective of age and sex will be included in the study.
排除标准
- •Patients having any systemic disease, which can compromise the healing response such as diabetes, patients on excessive medications, on immuno-suppressants, those receiving RT or CT etc.
- •will not be included.
结局指标
主要结局
Complete control and resolution of clinical signs
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
and symptoms of periapical disease, such as
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
pain, swelling, inflammation and restoration of
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
function
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
Radiographic evidence of healing of periapical
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
lesions showing disappearance or reduction in
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
size of the lesion or atleast arrest of lesion size
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
(not increasing)
时间窗: followed up at 3, 6 months, 1, 1 ½ and 2 years
次要结局
- Formation of a natural, biological seal of(mineralized tissue at the root apices)
