Effect of Age on the Success of Direct Pulp Capping Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis: A Prospective Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.
研究概览
简要总结
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim & Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents.
详细描述
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim & Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents based on clinical and radiographic findings and assessment of post operative pain for 7 days post treatment.
Statistical method: - Data analysis by suitable statistical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients and the outcome assessors will be blinded to the allocation groups (double-blinding). But the operator (Principal investigator) will not be blinded due to the nature of the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients (ASA I and ASA II).
- •Patients falling in the age group of 18-60 years.
- •Restorable permanent mandibular posterior teeth.
- •Extremely deep caries penetrating the entire thickness of dentine and exhibiting signs and symptoms of reversible pulpitis.
- •Teeth responding positively to cold test and electric pulp testing with no tenderness on percussion.
排除标准
- •Primary teeth.
- •Traumatic or mechanical exposure.
- •No pulp exposure after caries excavation.
- •Hemostasis not achieved within 10 mins.
- •Teeth with irreversible pulpitis.
- •Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.
- •Patients with periodontal disease, swelling and sinus tract.
- •Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic use within 1 month and analgesic use within week before the treatment.
结局指标
主要结局
clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.
时间窗: Baseline to 18 months
CLINICAL SUCCESS CRITERIA * Absence of sign and symptoms of pain on stimulus or spontaneous pain. * Absence of tenderness to palpation or percussion and presence of functional tooth. * Absence of any soft tissue swelling sinus or fistula. * Normal tooth mobility and no periodontal probing depth. * Positive response to pulp sensibility test (cold and EPT). RADIOGRAPHIC SUCCESS CRITERIA * Periapical Index (PAI) score ≤2. * Absence of external or internal root resorption. Also, to evaluate the effect of age on the success of procedure.
次要结局
- Post operative pain Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment.(Base line to 7 days)