Comparative Evaluation of Bio-C Repair, NeoPUTTY and Mineral Trioxide Aggregate as Pulpotomy Agents in primary molars: An in vivo study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare and evaluate the efficacy of Bio-C Repair, NeoPUTTY, and Mineral Trioxide Aggregate (MTA) as pulpotomy agents in primary molars.
研究概览
简要总结
The selected patients will be randomly assigned to three groups using Research Randomizer (Version 4.0), according to the pulpotomy agent used.
Group I – Bio-C Repair will be used as the pulpotomy agent in primary molars.
Group II – NeoPUTTY will be used as the pulpotomy agent in primary molars.
Group III – Mineral Trioxide Aggregate (MTA) will be used as the pulpotomy agent in primary molars.
CLINICAL PROCEDURE
Preoperative clinical and radiographic examinations will be done to ensure proper case selection. Local anesthesia will be administered followed by rubber dam isolation. All the carious tissue will be removed and the coronal pulp will be amputated using a sterile sharp spoon excavator or sterile slow-speed round bur until the orifices could be seen. Hemostasis will be achieved with the help of sterile saline moistened cotton pellets. Following hemostasis, the respective group pulpotomy agent will be applied.
Group I - Bio-C Repair will be applied directly on the exposed pulp and then will be adapted with a moistened cotton pellet.
Group II - NeoPUTTY will be applied directly on the exposed pulp and then will be adapted with a moistened cotton pellet.
Group III - MTA will be prepared by mixing MTA powder with distilled water on a sterile mixing glass slab. The mixture will be carried to the pulp chamber and will then be condensed and adapted with the help of a moistened cotton pellet.
After the application of the pulpotomy agent, the tooth will be restored with glass ionomer cement followed by the placement of stainless steel crown.
Further follow-up visits will be planned at 1, 3, 6, and 9 months for clinical and radiographic analysis based on modified Zurn and Seale’s scoring criteria (Musale and Soni, 2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy and cooperative children in the age group of 4-8 years.
- •No history of spontaneous or persistent pain.
- •Restorable primary molars with deep carious lesions approximating or reaching the pulp.
- •No pain on percussion
- •No pathological mobility
- •No Periodontal ligament widening as seen in the radiograph
- •No pathological internal or external root resorption.
- •No apical or furcal radiolucency.
- •Hemostasis achieved within 5 minutes of coronal pulp amputation.
排除标准
- •Uncooperative patient.
- •Patients with a history of allergy to local anesthetics.
- •Medically compromised patient.
- •Non-restorable tooth.
- •Tooth with periapical or furcal radiolucency.
- •The tooth with internal or external root resorption.
结局指标
主要结局
To compare and evaluate the efficacy of Bio-C Repair, NeoPUTTY, and Mineral Trioxide Aggregate (MTA) as pulpotomy agents in primary molars.
时间窗: at 1, 3, 6 and 9 months post opertaively.
次要结局
- 1. To evaluate the efficacy of Bio-C Repair as a pulpotomy agent in primary molars.(2. To evaluate the efficacy of NeoPUTTY as a pulpotomy agent in primary molars.)
研究者
Dr Nitika Bajaj
Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India