Comparative Evaluation of Treatment Outcomes Of Indirect Pulp Capping Using Calcium Hydroxide, Bio-C Repair, And Calcimol-LC In Permanent Mandibular First Molars With Deep Carious Lesion: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
研究概览
简要总结
This clinical trial will be conducted in the Department of Conservative Dentistry and Endodontics, Himachal Dental College & Hospital, Sundernagar, Himachal Pradesh.
After obtaining informed consent from the patients (Annexure I attached), they will be randomly allocated into three groups:
Group A: Calcium Hydroxide
Group B: Bio-C Repair
Group C: Calcimol LC
For the purpose of the clinical trial, the pulpal response using Electric Pulp Test (EPT) and cold test will be recorded as a baseline reference.
If required (in cases of severe sensitivity during cavity preparation, rinsing, or in patients with dental phobia), the tooth will be anesthetized using 2% lignocaine containing 1:80,000 adrenaline. Isolation of the tooth will be achieved using a rubber dam.
A sterile diamond bur will be used in a high-speed handpiece under constant water spray. Carious tissue will be identified and removed with the aid of a caries detector dye. The dye will be applied to cavity walls to stain demineralized carious tissue, allowing precise identification of infected dentine.
Stained, demineralized tissue will be removed, starting from the peripheral walls toward the center of the lesion. Selective caries removal will be done carefully to reach relatively firm, non-stained dentine. This step will be guided by both visual and tactile feedback to avoid accidental pulp exposure.
Necrotic carious fragments will be removed with a spoon excavator, followed by a round bur in a low-speed handpiece with water cooling. A fresh sterile bur will be used in deeper areas of the lesion to reduce microbial contamination and prevent the introduction of infected dentine into the pulp.
The prepared cavity will be rinsed with normal saline to remove residual dye and then gently dried.
Pulp capping material (based on group allocation) will be applied to the cavity floor. This material will be covered by a layer of Glass Ionomer Cement (GIC).
Subsequently, the cavity will be restored with composite resin.
Pulpal response using EPT and cold test will be evaluated at 1 week, 3 months, and 6 months post-procedure for follow-up and clinical assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 40.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients aged between eighteen to forty years.
- •Presence of deep carious lesions without pulp exposure, with radiographic depth reaching three-fourths of the dentin.
- •Positive response to pulp sensibility tests, including Electric Pulp Test and cold test.
- •No history of spontaneous pain.
- •No evidence of periodontal ligament space widening.
- •Permanent molars with adequate coronal tooth structure suitable for restoration.
排除标准
- •Presence of periapical pathology such as periapical radiolucency or root resorption.
- •Extensive loss of coronal tooth structure requiring prosthetic rehabilitation.
- •Presence of caries extending below the gingival margin.
- •History of chronic or recurrent pain associated with the affected tooth.
- •Presence of soft tissue swelling or sinus tract.
- •Teeth that have been previously treated endodontically or restored in the area under study.
- •Patients with known systemic health complications.
结局指标
主要结局
Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
时间窗: Check pulpal response using EPT/Cold Test at intervals of 1 week, 3 months and 6 months post-procedure.
次要结局
- Clinical symptoms & comparative success rates(1st week 3 month & 6 month)
研究者
Dr Diksha Kumari
Himachal Dental College and Hospital Sundernagar