Antibacterial Effect of Light-activated Calcium Silicate Versus Calcium Hydroxide on Permanent Carious Molars Treated With Step-wise Excavation (A Randomized Clinical Trial)
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Bacterial Count
研究概览
简要总结
This is a randomized clinical study. 48 subjects with a confirmed diagnosis of deep carious molars without pulpal lesions were randomized to one of two treatments: Patients treated with Light-cured calcium silicate (Theracal) liner, or treated with light-cured calcium Hydroxide (Biner LC) liner. Both two Treatments are with the step-wise excavation Technique.
Treatment will be done at baseline, collecting dentin sample before application of liner material, then patients will be dismissed with Resin-modified Glass Ionomer restoration and recalled after 6 months. Re-entry of tooth required for completing the step-wise excavation technique collecting the second dentin sample after this time interval (6 months) and permanently restore tooth with composite restoration. Dentin samples will be microbiologically analyzed and the results will be statistically calculated.
详细描述
- Study setting:
This study will be carried out on adult patients attending to the operative clinic in The Faculty of Oral and Dental Medicine, Cairo University, Egypt. The procedures will be carried out by postgraduate student Hanaa Mohamed Morsy [B.D.S. 2011 from Misr University for Science and Technology] without an assistant. 2. Variables of the study: A total of 48 carious lesions will be included in the study. Divided into two groups 24 each. Thus 48 dentin samples will be collected from each group (24 pre-operative dentin sample and 24 dentin sample after 6 months post-operative) 3. Trial Description:
• Grouping of participants: Patients will be diagnosed to find carious molars reaching dentin level. Participants will be divided to two groups randomly according to the type of liner that will be placed and sample of dentin that will be taken before placement of liner and after placement (6 months); D1 Dentin sample before and after treatment with light-cured Calcium Silicate (Theracal) {n=48}, and D2 Dentin sample before and after treatment with light-cured Calcium Hydroxide ( Biner LC){n=48}.
• Intervention/ Control: The procedure will be formed by removing the caries tissue till reaching dentin, leaving the deep layer for the application of the step-wise technique. Dentin sample will be taken by a spoon excavator for both groups and stored in a media to be transferred to the microbiological lab for analysis at the time baseline of the study (T1). Liner will be applied in the cavity for Group D1 using Theracal, and D2 using Biner LC. For both two groups, molars will be restored with Glass Ionomer restoration at the time baseline. Patients will be recalled after 6 months for the re-entry of the restored teeth , removing the Glass Ionomer restoration and collect the dentin sample (T2) for evaluation of the microbiological count. Finally restoring the teeth with Composite as the final permanent restoration. the procedure will follow the manufacturer's instructions for every material used.
• Outcome: The outcome will be the bacterial count of Streptococcus Mutans of the dentin samples collected from the tooth included in the study. Agar Diffusion test and Digital Colony Counter will be conducted for the study. The measuring unit of the bacterial count is CFU/ml. The first dentin sample will be collected in the baseline time and the second dentin sample after 6 month for each group.
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
It will be a single-blinded study so that the participant will be blinded, the researcher and the data analysis will be unblinded.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
- •Subjects aged between 18-40 years.
- •In each patient required one or two deep carious tooth occlusally either upper or lower permanent molars.
- •All volunteers must be with good oral hygiene in order to restore with composite restorations.
- •Subjects were required to be available for the duration of the study, and to sign an informed consent form
排除标准
- •Subjects with a history of allergy to any of the drugs or chemicals used in the study.
- •Subjects with carious anterior tooth are not within the study.
- •History of pulp pathology of the teeth which indicates root canal treatment is not included in the study.
- •Pregnancy and Lactating mothers.
- •Patients with any systematic problems or mental or physical disability.
研究组 & 干预措施
Light-cured calcium silicate
This biomaterial calcium silicate is manufactured to have an anti-bacterial effect on micro-organisms within the dentin, thus allowing the inhibition of bacterial growth therefore no caries will progress. Material is injected and light-cured within the dentin and sealed with a restoration.
干预措施: TheraCal (Drug)
Light-cured calcium hydroxide
This biomaterial calcium hydroxide is manufactured to have an anti-bacterial effect on micro-organisms within the dentin, thus allowing the inhibition of bacterial growth therefore no caries will progress. Material is injected and light-cured within the dentin and sealed with a restoration.
干预措施: light-cured calcium hydroxide (Drug)
结局指标
主要结局
Bacterial Count
时间窗: an average of 6 months
will be done by Digital colony counter, Agar Diffusion Test The measuring unit of the bacterial count is CFU/ml(colony-forming units per milliliter) for liquids). The first dentin sample will be collected in the baseline time and the second dentin sample after 6 month for each group.
次要结局
未报告次要终点
研究者
Hanaa Mohamed Morsy Mohamed
Master student at conservative department
Cairo University