Comparative Evaluation of the Treatment Outcome of Complete Pulpotomy using two different Calcium Silicate Biomaterials in Mature Permanent Molars with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial with a 1 Year Follow-Up
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- To determine the clinical success and radiographic outcome of tricalcium silicate and calcium silicate glass biomaterials following complete pulpotomy in teeth with symptomatic irreversible pulpitis.
研究概览
简要总结
The objective of pulpotomy in permanent teeth is to preserve the vitality of the pulp, which exhibits superior healing potential and clinical outcomes compared to direct pulp capping and root canal treatment. Pulpotomy is considered to be advantageous over root canal therapy (RCT) with respect to procedural complexities and economic factors in cases of symptomatic irreversible pulpitis(SIP). The pulpotomy procedures are performed to remove irreversibly inflamed pulp tissue and protect the residual normal/reversibly inflamed pulp tissue. In the literature, two distinct pulpotomy techniques have been described. This includes complete pulpotomy (CP), in which the entire coronal pulp tissue is removed up to the level of the root canal orifice(s) and partial pulpotomy (PP), which involves partial removal of coronal pulp tissue after exposure; prior to the application of a biomaterial and placement of a permanent restoration in both the cases. Based on a systematic review, the average success rate reported for CP was found to be 97.4% clinically and 95.4% radiographically at 12- months follow-up whereas for PP the average success rate reported was 92% at 2-year follow-up in treating cariously exposed permanent posterior teeth diagnosed with SIP.
Thus, the aim of this study is to evaluate the clinical and radiographic outcome of complete pulpotomy/VPT procedure performed usingtricalcium silicate and calcium silicate glass biomaterials in permanent molars with SIP. The total of 396 patients who meet the inclusion criteria will be enrolled for the clinical trial and two biomaterials will be used to perform complete pulpotomy in teeth diagnosed with****symptomatic irreversible pulpitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Teeth diagnosed with Symptomatic Irreversible Pulpitis.
- •Mature Permanent molars.
- •Healthy patients (age 18-30 years) without systemic diseases or allergic reactions (ASA I and ASA II).
- •No associated pathologic mobility of the tooth.
- •No significant periapical changes, periapical index (PAI) ≤
- •Active bleeding pulp tissue observed upon access opening.
排除标准
- •1.Teeth with pathologic mobility, associated sinus tract, necrotic pulp tissue (i.e., absence of hemorrhage in pulp chamber), or unrestorable teeth.
- •2.PAI score more than
- •3.Teeth with radiolucency in the furcation area, presence of internal or external root resorption, or pulp canal obliteration.
- •4.Teeth in which hemostasis cannot be achieved within 10 minutes.
- •5.Individuals not giving written consent.
- •6.Pregnant and lactating mothers.
结局指标
主要结局
To determine the clinical success and radiographic outcome of tricalcium silicate and calcium silicate glass biomaterials following complete pulpotomy in teeth with symptomatic irreversible pulpitis.
时间窗: Post-operatively- 24 hours, 3 months, 6 months, and 1 year. | Follow-up radiographs will be taken at 3 months, 6 months, and 1 year.
次要结局
- To comparatively evaluate the radiopacity of tricalcium silicate and calcium silicate glass biomaterials.(Time Points-3 months, 6 months, and 1 year.)
研究者
Pravin Kumar
All India Institute of Medical Sciences