Comparative Analysis of Long term Retention Properties of Glass Ionomer Cement and Pit and Fissure Sealants in 9 to 15 years aged Socially Disabled Children in Puducherry using Simonsens Criteria Split Mouth Technique
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Long-term Retention Properties of Glass Ionomer Cement and Resin based Pit and Fissure Sealants and comparative analysis of caries prevention
研究概览
简要总结
AIM : To compare the long term retention property of Glass ionomer cement and Resin based pit and fissure sealant in 9-15 years aged socially disabled children
RESEARCH QUESTION:Is there a difference in the retention property of glass ionomer cement and Pit and Fissure sealants in permanent teeth.
STUDY POPULATION:Orphanage socially disabled children of age 9-15 years
SAMPLING PROCEDURE:The sampling method by which the study subjects would be selected is Simple Random Sampling.
SAMPLE SIZE:The sample size was calculated using Formula, The calculation was based on a study “A comparative evaluation of retention of pit and fissure sealants placed with conventional acid etching and Er,Cr:YSGG laser etching: A randomised controlled trial†the Proportion of Retention rate in group L over 12 months follow up period from a this study conducted by Gyanendra Kumar et al (2016) With 88% proportion and alpha error 5%, the total minimum sample size was calculated to be 66, n=33 in each group. . Anticipating a 10% loss to follow up, the sample size is calculated as 37 per group (n=37). Thus, the total sample size N=74.
METHODOLOGY: The study subjects will be selected based on the inclusion criteria and exclusion criteria. The study sites will be randomly allocated into 2 groups namely Group A and B,Before the experiment, each participant will undergo baseline screening to confirm the dentition status and Caries risk Assessment will be done prior to intervention, after intervention follow up will be done in 3rd month , 6th month , 9th month.
INTERVENTION: Interventions for Group A The split mouth technique will be used where teeth to be treated will be isolated with cotton roll to ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant. Interventions for Group B:The split mouth technique will be used where teeth to be treated will be isolated with a novel cotton roll we planned to build which ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant.The Pink Pit and fissure sealant will be used, where the teeth to be treated were isolated with a novel cotton roll we planned to build ensuring proper isolation and long salivary retention preventing contamination of saliva and sealant. First the tooth will be etched with 37% phosphoric acid for 15 seconds, rinsed with water for 20 seconds.Sealant application using a syringe needle tip and checked for air bubbles and light curing is done for 20 seconds,Pit and fissure sealant is checked for any presence of high points ,Oral hygiene instructions will be given to maintain good oral health
follow up will be done in 3rd month , 6th month and 9th month
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 Blinded
入排标准
- 年龄范围
- 9.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Study subjects aged 9-15 years in the mixed and permanent dentition Presence of deep pit and fissure morphology suitable for sealant application Absence of existing dental caries in the teeth to be included in the study Willingness of parents legal guardians institution to provide consent for the child participation in the study Pits and fissures of permanent teeth in children and adolescents when the tooth or the patient is at risk of experiencing caries Individuals with Presence of Bilateral pit and fissure indicative tooth are included.
排除标准
- •Teeth with extensive dental caries requiring immediate restorative treatment Teeth with developmental anomalies or structural defects that render them unsuitable for sealant application Children with medical conditions or undergoing treatments that may interfere with the study outcomes or pose risks during dental procedures Children with behavioural issues or cognitive impairments that prevent cooperation during dental procedures Inadequate parental legal guardian consent for participation in the study Subjects with no dental caries in the oral cavity Physically impaired Children.
结局指标
主要结局
Long-term Retention Properties of Glass Ionomer Cement and Resin based Pit and Fissure Sealants and comparative analysis of caries prevention
时间窗: Retention will be checked in 3rd month , 6th month and 9th month
次要结局
未报告次要终点
研究者
Dr Vignesh Kumar P
Indira Gandhi Institute of Dental Sciences