A RANDOMIZED DOUBLE-BLIND ACTIVE CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFECT OF USE OF ADHESIVES ON THE CLINICAL OUTCOME IN CLASS V RESTORATIONS USING CENTION N , A DIRECT FILLING ALKASITE MATERIAL & PACKABLE GLASS IONOMER CEMENT IN CHILDREN AND YOUNG ADULTS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- dentinal hypersensitivity shall be checked using Visual Analog Scale with the help of air blast using a three way syringe and tactile sensitivity shall be checked using 17/23 explorer repeated three times before recording.
研究概览
简要总结
Traditionally resin based glass ionomer cements and advanced composites are used to treat non carious cervical lesions. Composites have an innate drawback of no ionic release and hence risk of secondary carious involvement. So Cention N could emerge as a good clinical option to treat such lesions.There is no evidence based update on Cention N so far. So a randomized clinical trial to evaluate the clinical outcome of this new material as a viable anterior esthetic material is undertaken to evaluate the use of Adhesives on the clinical outcome i.e retention, marginal adaptation anatomic forms surface texture and secondary caries in class v restorations using cention N as a direct filling material in children and young adults and to evaluate post-operative sensitivity in class V restorations using Cention N a direct filling material in the same individuals.
A total sample of approximately 32 individuals belonging to age group of 5-14 year old reporting to Seema Dental College and Hospital having bilateral carious class V cavities shall be selected based on the inclusion and exclusion criteria. Of the 32 individuals two sub groups ie. Test and control group shall be made each containing 16 individuals. In the test group every individual shall be subjected to split mouth technique where Cention N with adhesive shall be used to restore the tooth on right side and without adhesive on left side.. Type IX GIC shall be used for control group.
| The sensitivity shall now be recorded using Visual Analog Scale with the help of air blast using a three way syringe and tactile sensitivity shall be checked using 17/23 explorer repeated three times before recording.The patients shall be given post-operative instructions and recalled after a period of 6 months interval for up to two years to evaluate the restorations using the USPHS- Ryge criteria for retention, marginal adaptation, anatomic form, surface texture and secondary caries. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •5-14 year old individual (both males and females) of districts of Uttarakhand.
- •Participants who have bilateral class V cavities in anterior teeth/premolars in primary/mixed /permanent dentition.
- •Individuals with a no systemic illness or psychological disorder of any kind 4)Individuals who do not have any removable appliance where the teeth in concern act as abutment tooth.
- •Individuals who do not have any malocclusion or TMJ related disorder.
- •The teeth in question should be periodontally sound and without any pulpal pathology.
- •Individuals who fulfill the research criteria and are ready to give the consent to participate in the study are considered for the study.
排除标准
- •Children below the age of 5years and above the age of 14 years.
- •Participants who refuse to participate in the study.
- •Subjects who are uncooperative for clinical examination during the study.
- •Subjects with any type of severe systemic disease or hypoplastic teeth or with persistent faulty oral habits.
- •Individuals with periodontally compromised teeth or pulpally involved anterior teeth / premolars.
- •Individuals who can’t comply for a follow up of upto 2 years.
结局指标
主要结局
dentinal hypersensitivity shall be checked using Visual Analog Scale with the help of air blast using a three way syringe and tactile sensitivity shall be checked using 17/23 explorer repeated three times before recording.
时间窗: 0,6months,12months,18months,24 months
次要结局
- retention, marginal adaptation, anatomic form, surface texture and secondary caries(0,6months,12months,18months,24 months)