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临床试验/CTRI/2018/05/013871
CTRI/2018/05/013871尚未招募Unknown

Clinical Evaluation Of Hydrophobic And Hydrophilic Pit And Fissure Sealants Among 7-10 Year Old School Children – An Interventional Study

G Indrapriyadharshini2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年5月21日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
The effect of sealant retention Will be assessed using modified simonson’s criteria

研究概览

简要总结

Asplit mouth design will be used in this study. These children will be randomlydivided into groups for either of the interventions. Group I (**hydrophobic pit and fissure sealants)**will be used and group II (hydrophilicpit and fissure sealants ) will be used.

Procedure forhydrophobic pit and fissure sealants:

Thesealant will be placed as follows under proper isolation with rubber dam.Occlusal surfaces of the teeth were etched with 37% phosphoric acid for 30seconds and rinsed with water. The teeth were then dried with a mild oil-freeair stream to achieve a characteristic frosty white, chalky appearance ofenamel. Two coats of bonding agent were applied and light cured for 20 secondsusing visible light curing unit. Sealants were then applied and cured accordingto the manufacturer’s instructions.

Procedure forhydrophilic pit and fissure sealants:

Occlusal surfaces of the teeth were etchedwith 37% phosphoric acid for 30 seconds and rinsed with water. With hydrophilicpit and fissure sealants, the typical dull, frosted appearance of the etchedsurface is not desired. Rather, the surface should be lightly dried and veryslightly moist with a glossy appearance. To accomplish this, a cotton pelletwas used to remove the excess moisture. No bonding agent was applied. The sealantwas applied as per manufacturer’s instructions followed by light curing for 40seconds.

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 Outcome Assessor Blinded

入排标准

年龄范围
7.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children aged 7-10 years with fully erupted mandibular permanent first molars bilaterally.
  • Children scoring 0 or 1 according to ICDAS II criteria for detecting caries in their mandibular permanent first molars.
  • Children who have low risk of caries based on caries risk assessment tool.
  • Children whose parents do wish to give consent.

排除标准

  • 1.Children presenting with caries,pulpal involvement and restorations.
  • 2.Children with any preventive measures carried out priorly.
  • 3.Children who have enamel defects like amelogenesis imperfecta, enamel hypoplasia and dental fluorosis.
  • Children who have space infections as a complication of the dentition.
  • Children undergoing orthodontic treatment.
  • Children who are under medications for any systemic illness altering the salivary composition and flow.
  • Children who are differentially abled.

结局指标

主要结局

The effect of sealant retention Will be assessed using modified simonson’s criteria

时间窗: at baseline,3 months,6 months

次要结局

  • 3.To evaluate and compare additional factors such as colour match, marginal discolouration, secondary caries, anatomic form, marginal adaptation and surface texture of proximal sealants and adhesive systems months using United States Public Health Service - Modified Ryge Criteria for Direct Clinical Evaluation of Restorations proposed by Cvar and Ryge, 1980(at baseline,3 months,6 months)

研究者

发起方
G Indrapriyadharshini
申办方类型
Other [self]

研究点 (2)

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