Evaluation Of The Efficacy Of Using Calcium-Silicate Based Sealers As A Pulp Capping Material After Adult Pulpotomy: An In-vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Cinical success after full pulpotomy procedure
研究概览
简要总结
This clinical study aims to assess the efficacy of using calcium silicate based sealer as a capping material after complete removal of coronal pulp tissue. The study will evaluate both the clinical and radiographic changes.
详细描述
Root canal treatment has always been considered the first line of treatment for carious teeth with symptomatic irreversible pulpitis for a long time. However, after the evolution of calcium silicate based materials a more conservative option, which is pulpotomy began to gain reliability, especially that it preserves the vitality of the radicular pulp, clinically simpler, less time-consuming, and more cost-effective compared to conventional root canal treatment.
In this study the investigators assess the clinical and radiographic success rate of using calcium silicate based sealer as a pulp capping material in permanent molars after pulpotomy.
For the best of the investigators' knowledge, there is no available clinical data on the use of calcium-silicate based sealers as a pulp capping material in pulpotomy of permanent molars with symptoms of irreversible pulpitis.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vital mandibular molar teeth with mature apices.
- •Teeth that respond positively to cold testing.
- •Teeth without any signs of necrosis including sinus tract or swelling.
- •Teeth with caries extending ≥ 2/3 of dentine or exposing the pulp.
- •Teeth with symptomatic irreversible pulpitis with/without apical periodontitis.
- •Teeth without periodontal diseases or mobility.
- •Teeth without root resorption, detectable pulp chamber and root canal calcification or history of trauma.
- •Patients from both genders with age range from 20 to 45 years old.
- •Patients with good or moderate oral hygiene and without any systemic diseases.
排除标准
- •Pre-operative criteria:
- •Non-vital teeth.
- •Teeth with irreversible pulpitis with apical periodontitis.
- •Teeth with immature apices.
- •Teeth with Periodontal disease or mobility grade II or III.
- •Teeth that are badly decayed and need post and core placement.
- •Patients refused to continue treatment procedures or refuse to commit to periodic follow-up sessions.
- •Non-restorable teeth.
- •Intra-operative criteria:
- •If hemostasis could not be achieved within 6 minutes after full pulpotomy.
- •Teeth with partial necrosis.
- •No bleeding after access cavity preparation.
- •Post-operative criteria:
- •presence of Swelling.
- •presence of Sinus tract.
- •Pain on percussion after the end of the first week.
- •Pain with palpation.
- •Pain on biting after the end of first week.
- •Mobility of the tooth.
- •Fracture of tooth structure that renders the tooth non-restorable.
- •Fracture of the restoration during the evaluation.
- •Probing depth more than 3 mm.
结局指标
主要结局
Cinical success after full pulpotomy procedure
时间窗: At 3 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Clinical success after full pulpotomy procedure
时间窗: At 12 months
Clinical evaluation of the targeted tooth is performed and the treatment is considered successful in case of: absence of post-operative pain, absence of pain on percussion and palpation, absence of any swelling related to the treated tooth, absence of sinus tract or fistula and absence of tooth mobility.
Radiographic success after full pulpotomy procedure
时间窗: At 12 months
Radiographic evaluation of the targeted tooth is performed and the treatment is considered successful in case of presence of normal periodontal ligament space, absence of internal or external root resorption, absence of canal calcification, absence of peri-radicular radiolucency and no loss or break of lamina dura.
次要结局
- Assessment of Post-operative pain after full pulpotomy procedure(6 hours, 24 hours, 48 hours, 72 hours and 7 days)
研究者
Mahmoud Yahia Ramadan Abdelsalam
Master Degree in Endodontics
Al-Azhar University