Role Of Wound Lavage in Direct Pulp Capping Of Permanent Teeth With Carious Exposure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- clinical and radiographic success at 6 and 12 months.
研究概览
简要总结
the purpose of the study is to investigate the outcome of wound lavage agents Sodium hypochlorite and Ethylenediaminetetraacetic acid (EDTA) in direct pulp capping of mature permanent teeth with carious exposure.
详细描述
With the growth of advanced pulp biology and bioactive materials today, management of deep carious lesions has come to a more conservative approach. Vital pulp therapy (VPT), comprising direct pulp capping, partial pulpotomy, and coronal pulpotomy, has been proposed as an alternative treatment to the traditional root canal treatment. Although there seems to be an agreement on the appropriate pulp dressing materials, the recommended irrigant for VPT in permanent teeth is less studied. Dentin matrix is a reservoir of bioactive molecules that are sequestered during dentinogenesis.The releasable growth factors from dentine provide source of cell signaling molecules for initiating repair and regeneration. Evidence shows that EDTA has ability to release growth factors from dentine matrix and it also promotes cell survival,attachment,growth and differentiation. Sodium hypochlorite has high efficacy against biofilms and its semi selective tissue dissolving properties on necrotic rather than vital soft tissue makes it ideal for dentin/pulp wound lavage.In direct pulp capping ,wound lavage with sodium hypochlorite has shown to reduce postoperative pain and early painful failures. However there is a lack of well designed clinical trials on pulp wound lavage.
The aim of this study is to investigate the outcome of wound lavage agents Sodium hypochlorite and EDTA in direct pulp capping of mature permanent posterior teeth with carious exposure Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics.Time Frame of the study will be 18 months and Patients of age 18-50 years will be enrolled in this study.
After caries excavation, patients will be randomly allocated into four groups- Group I-normal saline, Group II-sodium hypochlorite, Group III-EDTA, Group IV-Sodium hypochlorite followed by EDTA. Washing of the pulp wound will be done with respective allocated solution and then tooth in both groups will be restored according to standard protocol.
Primary outcome variables recorded will be clinical and radiographic success rates after 6 and 12 months from the treatment.
Secondary outcome measure will be reduction in post operative pain after 7days of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient willing to participate in the study.
- •Age group- 18-50 years.
- •Mature permanent mandibular posterior teeth (molars or premolars) with reversible pulpitis.
- •Teeth with extremely deep caries (Caries penetrating entire thickness of dentine) responding within normal limits to the cold test and Electric pulp test.
- •Teeth with normal apical tissues(not showing any rarefaction on the intraoral periapical radiograph)
排除标准
- •Primary teeth.
- •Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract, and furcation or apical radiolucency.
- •Immuno-compromised, diabetic, pregnant and hypertensive patients.
- •Positive history of antibiotic within past one month and analgesic since one week use of the treatment
结局指标
主要结局
clinical and radiographic success at 6 and 12 months.
时间窗: 12 months
Clinical success criteria- * Positive response on cold testing * Absence of sign and symptoms of spontaneous pain or pain on stimulus and discomfort. * No tenderness to palpation or percussion and the tooth is functional. * Normal tooth mobility and no periodontal probing pocket depth. * Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria- * Absence of any periapical or interradicular radiolucency * Absence of internal or external root resorption * Periapical Index score \< 2 according to Orstavik et al.
次要结局
- To assess postoperative pain .(7 days)