Efficacy Of Chemomechanical Method of Caries Removal Using BRIX- 3000 in vital pulp therapy- A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Assessing the pain scores (HP VAS) and time (T) taken for deep caries excavation using chemomechanical method of cavity preparation as compared to conventional method.
研究概览
简要总结
AIM - The purpose of the current study was to evaluate the efficacy of chemomechanical method of caries removal using BRIX 3000 as compared to conventional caries excavation with burs in vital pulp therapy
METHODOLOGY - The double-blind randomized control trial was conducted on 134 patients who were randomly divided into chemomechanical caries removal with BRIX 3000(Group I - 67 patients) and high-speed bur excavation with aerator (Group II - 67 patients). Time (T) required for cavity preparation and pain perceived by the patients (HP - VAS scores) were recorded. After the final restoration patients were recalled at the end of 1,3 and 6 months for follow-up. During the follow-up recalls the success of pulp capping procedures was recorded by calibrated examiners who evaluated the pulp (Endo frost, Dry Ice) and periapical status (IOPA). The results were statistically analyzed by Independent sample t-test and Mann Whitney U test.
CONCLUSION - The primary outcome measures suggested more time taken with BRIX 3000 as compared to high-speed burs. however, the patient felt more comfortable and the HP VAS scores are significantly lower for BRIX 3000. This method can eliminate the need for local anesthesia for deep caries excavations.
BRIX 3000 effectively removed only the carious dentin leaving behind sound dentin for remineralization, this will lead to increased success rates achieved in pulp capping procedures. BRIX 3000 is an important aid in this revolution towards minimally invasive dentistry and is an important material in the dental arsenal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Bilateral open carious lesion with dentin involvement 2.Opening should be large enough to allow penetration of a small excavator 3.No proximal caries as evidenced by intra oral periapical radiographs •Teeth without clinical or radiographic evidence of pulp, furcation or periapical pathology.
排除标准
- •1.History of pain and pulp exposure.
- •2.Presence of sinus opening with pus discharge and radiographic evidence of furcation or periapical pathology.
- •3.Hypersensitivity to any of the component of BRIX 3000.
结局指标
主要结局
Assessing the pain scores (HP VAS) and time (T) taken for deep caries excavation using chemomechanical method of cavity preparation as compared to conventional method.
时间窗: HP VAS scale taken after cavity preparation (post procedure). Time taken for the procedure recorded.
次要结局
- Higher success rates of vital pulp therapy when BRIX 3000 CMCP is used(1, 3 and 6 months post-treatment)