Clinical Evaluation of Direct Pulp Capping in Primary Molars
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- clinical success of direct pulp capping treatment after 3 months follow up
研究概览
简要总结
The purpose of this study is to Assess the effect of MTA and hard setting Calcium Hydroxide (Dycal) on the clinical and radiographic outcome of direct pulp capping in primary molars and evaluate overall success rate of direct pulp capping in primary molars.
详细描述
After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in patient examination sheet.
Participants who met the inclusion criteria were randomly allocated to two groups (n = 26/group, N = 52 in total) according to the capping martials using the envelope randomization method.
2 study groups according to capping material that will be used (Dycal or MTA) and each group will be divided to 2 subgroups according to site of exposure axial or pulpal.
All patients were recalled and their treated molars were evaluated clinically and radiographically at 3months, 6months, 9months ,12months follow up periods.
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
- Single (Participant)
盲法说明
capping material used
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cooperative child and compliant parent.
- •Complete physical and mental health.
- •Children who are known to be healthy and free from systemic diseases.
- •Primary molars with deep carious lesions leading to pathological exposure but with no signs or symptoms of irreversible pulpitis or necrosis such as spontaneous pain, tenderness to percussion, abscess, fistula, periodontal tissue swelling, or abnormal tooth mobility.
排除标准
- •A deep carious lesion in close proximity to the pulp with an intact lamina dura.
- •Absence of widening of periodontal membrane space or radiolucency at the furcation and periapical region.
- •Absence of pulpal calcifications, obliteration of the pulp and root canal, or internal/external root resorption.
结局指标
主要结局
clinical success of direct pulp capping treatment after 3 months follow up
时间窗: 3 months
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
radiographic success of direct pulp capping treatment after 9 months follow up
时间窗: 9 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
radiographic success of direct pulp capping treatment after 12 months follow up
时间窗: 12 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
clinical success of direct pulp capping treatment after 6 months follow up
时间窗: 6 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
clinical success of direct pulp capping treatment after 12 months follow up
时间窗: 12 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
clinical success of direct pulp capping treatment after 9 months follow up
时间窗: 9 months follow up
Presence of any of these clinical findings will be considered failure: pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around the crown margin denoting bad oral hygiene. pain on percussion on clinical examination . non-physiologic mobility. fistula or sinus tract.
radiographic success of direct pulp capping treatment after 3 months follow up
时间窗: 3 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
radiographic success of direct pulp capping treatment after 6 months follow up
时间窗: 6 months follow up
the absence of the following radiographic findings indicate the success of capping material in pulp therapy: * pathological internal or external root resorption. * PDL widening. * inter-radicular radiolucency formation postoperatively. * periapical radiolucency formation postoperatively.
次要结局
未报告次要终点
研究者
Nayera tarek
PhD researcher of Pediatric Dentistry and Dental Public Health, Mansoura University
Mansoura University