Clinical Performance of Alkasite-Based Resin Versus Nanohybrid Composite Resin Restorations for Occlusal Carious Lesions in 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
- Incidence of secondary caries
研究概览
简要总结
The aim of this study is to evaluate and compare the clinical performance of alkasite-based resin and nanohybrid composite resin materials in the restoration of occlusal carious lesions in primary molars of children.
详细描述
This randomized clinical trial aims to evaluate and compare the clinical performance of an alkasite-based resin restorative material (Cention N®) and a nanohybrid composite resin (TPH Spectra ST Universal Composite) in restoring occlusal carious lesions (Class I) in primary molars among children aged 4-6 years. Participants will be randomly allocated in a 1:1 ratio into two parallel groups and followed for a period of 12 months. The primary outcome will be the incidence of secondary caries assessed at 3, 6, and 12 months using the United States Public Health Service (USPHS) criteria, which grades restorations from Alpha (ideal/excellent) to Delta (failure). Secondary outcomes will include the evaluation of restoration fracture, marginal adaptation, marginal discoloration, surface roughness, and retention, all assessed at the same intervals using the same USPHS criteria.
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)
盲法说明
The children, outcome assessors, and the statistician will be blinded to the study.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Children aged 4-6 years of both sexes.
- •Cooperative children.
- •Apparently medically fit children according to parental history.
- •Children whose parents agree to sign the informed consent.
- •Children whose parents will be able to attend the follow-up.
- •Primary molars with occlusal carious lesions (Class I), indicated for direct restorations.
- •Teeth without signs of pulpal involvement, abscess, or fractures.
排除标准
- •Children with systemic or mental disorders.
- •Children whose parents refused to sign the informed consent.
- •Noncompliant parent.
- •Uncooperative children.
- •Teeth with deep caries involving the pulp or clinical signs of pulpal infection (e.g., swelling, sinus, fistula, pathological mobility).
- •Teeth with periapical pathology, internal or external root resorption, or mobility.
- •Non-restorable teeth or lacking sufficient structure for restoration
研究组 & 干预措施
Alkasite-based Restorations (Cention N)
The children assigned to this intervention group will have alkasite-based restorations for the treatment of Class I carious lesion in primary molars.
干预措施: Alkasite-based composite restorations (Other)
Nano-hybrid composite resin restoration (TPH Spectra ST Universal Composite).
The children assigned to the comparator group will undergo class I cavity restorations using nano-hybrid resin composite
干预措施: Nano-hybrid resin composite (Other)
结局指标
主要结局
Incidence of secondary caries
时间窗: 12 months
The primary outcome of this study will be the evaluation of secondary caries incidence at 3, 6, and 12 months following restoration. Assessment will be carried out using the United States Public Health Service (USPHS) criteria, with restorations scored on a scale ranging from Alpha (clinically excellent) to Delta (clinically unacceptable. Each restoration will be scored as Alpha (A) if there is no evidence of secondary caries and the tooth-restoration interface remains intact. A score of Bravo (B) will indicate a questionable or suspicious area, such as slight marginal staining without definite cavitation. Charlie (C) will be assigned when definite secondary caries are observed, including softness or cavitation at the restoration margin, necessitating replacement of the restoration. Delta (D) will be used for severe carious lesions extending beneath the restoration, requiring immediate intervention.
次要结局
- clinical evaluation of restoration fracture(12 months)
研究者
Yusra hashim Mohamed kheir khogali
Master's degree student
Cairo University