Clinical Performance and Antibacterial Effect of a Bulk Fill Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars(Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical performance of the restorations using Modified Ryge's Criteria
研究概览
简要总结
The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.
详细描述
A two-arm randomized controlled clinical trial. A total of 40 healthy cooperative children aged 5-9 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Each child selected will have second primary molar with occluso-proximal carious lesions indicated for pulpotomy. Written informed consent will be obtained from their guardians. After the MTA pulpotomy procedure, participants will be randomly allocated into two groups according to the restoration used. Group I (test group n=20) will receive Cention Forte material, while group II (control group n=20) will receive conventional SSC. Using Modified Ryge's Criteria, the clinical performance of the restorations will be evaluated at 1 week and then after 3, 6 and 12 months for marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness and secondary caries. Periapical radiographs will be taken at baseline and after 6 and 12 months. Also, the antibacterial effect of the restorations on salivary cariogenic bacterial count will be assessed at baseline and after 1 week, 1 month and 3 months. Plaque and Gingival index scores as well as parental and child's satisfaction will be recorded.
Data will be collected, tabulated, and statistically analysed to obtain the results and conclusions of this study.
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 (Outcomes Assessor)
盲法说明
Outcome assessor, statistician and the microbiologist are blinded
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cooperative children (Positive or definitely positive) according to the Frankl's behaviour rating scale.
- •Children free of any systemic disease or special health care needs (ASA1).
- •Completion of an informed consent to participate in the study.
- •Second primary molar tooth with occluso-proximal carious lesions indicated for pulpotomy.
- •Restorable tooth.
- •Radiographically at least two-thirds of the root length is present.
- •Presence of neighboring and opposing teeth.
排除标准
- •Clinical signs or symptoms of irreversible pulpitis or non- vitality.
- •Radiographic signs of degeneration including internal or external root resorption, furcation involvement.
- •Pathologic mobility detected by placing the points of a pair of tweezers in the occlusal fossa and gently rocking the tooth buccolingually.
- •Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
- •Child with parafunctional habits.
研究组 & 干预措施
Cention forte material
干预措施: Cention Forte alkasite bioactive restorative material (Other)
Stainless steel crown
干预措施: Stainless steel crown (Other)
结局指标
主要结局
Clinical performance of the restorations using Modified Ryge's Criteria
时间窗: One year
The clinical evaluation of the two restorations will be done using parameters of marginal adaptation, proximal contact, retention, gross fracture, occlusal wear, surface roughness, and secondary caries as per the modified United States Public Health Service (USPHS) Ryge's criteria. Scores for the modified Ryge's criteria are as follow: * alpha: represents the ideal or excellent condition of a restoration * bravo: indicates a clinically acceptable restoration with minor defects * charlie: indicates restoration is unacceptable clinically and should be replaced
The antibacterial effect of both restorations on salivary cariogenic bacterial count.
时间窗: 3 months
The saliva samples will be collected to assess microbiological colony count of S.mutan and lactobacilli at baseline, after 1 week, 1 month and 3 months.
次要结局
- Radiographic success of pulpotomized second primary molars in both groups(One year)
- Gingival index(One year)
- Child satisfaction(Over one year)
- Plaque index(One year)
- Parental satisfaction(Over one year)
研究者
Noha Fouad
Assistant lecturer of Pediatric Dentistry, Faculty of Dentistry, Alexandria University
Alexandria University