Evaluation of Fluoride Release and Compressive Strength of a Bioactive Restorative Material and Its Clinical Performance in Atraumatic Restorative Treatment in Primary Molars (An in Vitro Study & A Randomized Controlled Trial )
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth
研究概览
简要总结
The study will be two parallel group, triple blinded randomized controlled clinical trial that based on CONSORT (consolidated standards of reporting trials) guideline .The selected participants according to inclusion and exclusion criteria will be randomly allocated in two groups using (Research Randomizer Program) .
详细描述
Blinding All participants don't know the type of received restorative material (ACTIVA Kids or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner other than operator who doesn't know the type of received restorative material also.
Study setting The study will be performed at pediatric Department and Dental Public Health Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate Studies and Research, Ain Shams University.
Sample size: 60 participants Recruitment/Setting The all participants of this study have been selected after complete clinical examination has been done with full medical and dental history , history of medications and history of hospitalization. In patients who receive dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health Department at faculty of dentistry, Ain-Shams University.
Informed consent designed to include all data about dental procedures in this study and clear more details about time consuming in the procedure and follow up visits, used materials and adverse event of this procedure . All participants have the wright to withdraw from this study at any time .The consent will be assigned from each patient by the patient's parents or guardians after explanation of the study.
The full mouth rehabilitation will be performed by postgraduate student registered at the master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Ain- Shams University All subjects receive instructions on oral health, particularly in relation to oral hygiene and sugar consumption
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged from 4 to 8 years old, in good general health
- •Children classified as class 3 or 4 based on Frankel et al. classification. (26)
- •The children have at least one primary molar with class I carious lesion.
- •Asymptomatic teeth (without spontaneous pain)
排除标准
- •Medically compromised patient
- •Presence of pulp exposure, pain, mobility
- •Presence of swelling, abscess or fistula near the tooth
- •Not accessible carious lesion to hand instruments
研究组 & 干预措施
Group I
Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach
干预措施: Fuji IX EXTRA (Drug)
Group II
Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
干预措施: ACTIVA KIDS bioactive restorative material (Drug)
结局指标
主要结局
the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth
时间窗: 12 Month
Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure.
次要结局
未报告次要终点
研究者
Marina F Fahmy, MD
Assistant lecturer of pediatric dentistry, pediatric dentistry and public health department, Ain Shams University
Ain Shams University