Clinical and Radiographic Evaluation of Calcium Hypochlorite Versus Saline As Root Canal Irrigants in Pulpectomy of Primary Molars: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Absence of post-operative pain.
研究概览
简要总结
The aim of this study is to evaluate the clinical and radiographic success of Calcium Hypochlorite versus Saline as root canal irrigants in pulpectomy of primary molars.
The research question it aims to answer is:
In pulpectomy of primary molars will the use of calcium hypochlorite as root canal irrigant result in superior clinical and radiographic success to saline?
详细描述
Dental caries is a progressive disease of the dental hard tissue that may lead to pulpal, periapical, and/or intraradicular infections if not managed in its initial stages. Treating caries in primary dentition is necessary to prevent the spread of bacteria, infection of the pulp, abscess, or facial cellulitis and to maintain tooth space.
The operator can choose the most appropriate treatment, including pulpotomy, pulpectomy, direct pulp capping, or indirect pulp capping, according to the child's signs and symptoms, pulp vitality, and radiographic evaluation.
Pulpectomy procedure involves the removal of the entire pulp tissue from the crown and root canals. Proper instrumentation, irrigation, and root canal obturation are all necessary for a successful pulpectomy. Root canal irrigants are essential for cleaning the root canal system, dissolving tissues, and removing the debris. Therefore, the choice of suitable root canal irrigant is important for the success of pulpectomy treatment.
Saline has been commonly used as a root canal irrigant for pulpectomy of primary molars with irreversible pulpitis; however, it only provides lubrication and cleaning actions without any tissue dissolving or disinfecting properties.
(Nelson-Filho et al., 2018) conducted a study to compare the bacterial contamination identified in the root canals of primary teeth with irreversible inflammatory pulpitis and in teeth showing apical periodontitis. The findings showed that there is almost always bacterial contamination of pulp tissue of primary teeth with irreversible pulpitis whenever the cause is carious pulp exposure.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Criteria:
- •Children aged between 4 years and 7 years.
- •Mandibular primary molars with deep caries lesion involving pulp.
- •Mandibular primary molars that exhibit symptoms of irreversible pulpitis.
- •Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- •No history of swelling, fistula or sinus tract related to the offending molar.
- •Radiographic criteria:
- •No sign of radiolucency in periapical or furcation area.
- •No widening of PDL space or loss of lamina dura continuity.
- •No evidence of internal/external pathologic root resorption.
排除标准
- •Uncooperative children to avoid time waste and attrition bias.
- •Children with systemic disease as some systemic diseases may have effect on the outcome (Segura-Egea et al., 2023).
- •Lack of informed consent by the child patient's parent to be approved ethically.
- •Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
- •Refusal of participation as the parent of child has the authority of participation.
- •Teeth near exfoliation time showing root resorption.
结局指标
主要结局
Absence of post-operative pain.
时间窗: 1-week changes from baseline pulp condition
Asking the patient and/or guardian. Outcome measuring unit: Binary (Yes/No)
次要结局
- Pathologic mobility(at 3,6,9 and 12 months changes from the baseline pulp condition.)
- Absence of Swelling/Sinus or Fistula.(at 3,6,9 and 12 months changes from the baseline pulp condition.)
- Absence of Pain to percussion(at 3,6,9 and 12 months changes from the baseline pulp condition.)
- Absence of furcation or periapical radiolucency.(at 6 and 12 months changes from the baseline pulp condition.)
- Absence of external or internal root resorption.(at 6 and 12 months changes from the baseline pulp condition.)
- Widening of periodontal membrane space(at 6 and 12 months changes from the baseline pulp condition.)
研究者
Yasmine Abdo Helmy ElAssar
Yasmine Abdo Helmy ElAssar
Cairo University