Clinical Evaluation of Giomer Based Injectable Resin Composite Versus Resin Modified Glass Ionomer in Class V Carious Cavities Over 18-months: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical performance (Marginal adaptation)
研究概览
简要总结
Class V carious lesions will be restored using either Resin modified glass ionomer or Giomer based injectable resin composite.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria.
详细描述
In this study, Class V carious lesions will be restored using two different restorative materials either Resin modified glass ionomer or Giomer based injectable resin composite. Patients will be assessed for medical and dental histories first. Then an examination of the patients will be done using visual inspection by using a dental mirror and probe. Eligible patients according to inclusion and exclusion criteria will be informed about all procedures with follow up time if they accept. Their signature on written informed consents will be obtained. Eligible participants will be randomly divided into two groups according to the type of restoration they will be received.The first group (A) (Intervention): Giomer based injectable resin composite (Beautifil Flow plus X F03, SHOFU, USA): The material will be applied according to manufacturer instructions. The second group (B) (comparator): Resin modified glass ionomer (Fuji II LC, GC): The material will be applied according to manufacturer instructions.The restorations will be evaluated at baseline and regular recalls of 3 months, 6 months, 12 months and 18 months, using modified United States Public Health Service criteria (USPHS) for the following characteristics: retention, anatomical form, marginal adaptation, marginal staining, surface texture, and secondary caries . The restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable, and Charlie represents a clinically unacceptable situation.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant Inclusion Criteria
- •Age 18-60 years.
- •Co-operative patients approving to participate in the study.
- •Male or female patients.
- •Patients with good general health
- •Moderate or high caries risk patient
- •Teeth Inclusion Criteria
- •Cervical Class V carious lesions.
- •Pulp asymptomatic vital carious teeth.
- •Participant
排除标准
- •Systemic disease or severe medical complications.
- •Participants with a history of allergy to any component of restorations will be used in the study.
- •Lack of compliance
- •Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits
- •Teeth Exclusion Criteria
- •Presence of apical or periapical pathosis.
- •tooth mobility
- •Non-vital teeth.
- •Teeth with advanced periodontal diseases.
- •Teeth which need indirect restoration.
研究组 & 干预措施
Giomer based injectable resin composite
Beautifil Flow plus X F03, SHOFU, USA
干预措施: Giomer based injectable resin composite (Device)
Resin modified glass ionomer
Fuji II LC, GC
干预措施: Resin modified glass ionomer (Device)
结局指标
主要结局
Clinical performance (Marginal adaptation)
时间窗: 18 months
Method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha, Bravo, charlie) as unit of measurement by Scoring %. Alpha is the best outcome and charlie is the worse outcome .
次要结局
- Clinical performance (Anatomical form, marginal discoloration, Secondary caries, surface texture , Postoperative sensitivity, Retention,)(18 months)
研究者
Reham Adel Yahia Hendam
assistant lecturer at conservative department,,faculty of dentistry, modern university for Technology and Information.
Cairo University