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临床试验/NCT04837469
NCT04837469已完成不适用

Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month

Ondokuz Mayıs University0 个研究点目标入组 13 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
主要终点
The evaluation of retention rate of fissure sealants

研究概览

简要总结

Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Methodology: 144 sealants were placed on the permanent premolars and molars of 13 subjects. Teeth were divided into three groups SB2(control): Adper Single Bond 2, SBU-ER: Single Bond Universal/etch-and-rinse, SBU-SE: Single Bond Universal/self-etch. After the adhesive application, Fissurit FX was applied and light-cured. Clinical evaluations were done at baseline and at 1 week, 6-, 12-, 18- and 24-month recalls. Visual examination was performed on every visit for evaluation of the sealants. Evaluating criteria were: 1= completely retained; 2= partial loss; 3= total loss. The Pearson Chi-square test was used for each evaluation period.

详细描述

Thirteen patients with a mean age of 20.5 (range 19-22) were selected among the patients seeking routine dental care from Conservative Dentistry Department who met the inclusion criteria. Inclusion criteria were: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.

Bitewing radiographs were taken. Pellicle and any remaining plaque on the fissures were removed by using slurry of pumice with a slow-speed handpiece. All restorative procedures were performed by the same operator. The teeth were assigned for different group by using a table of random numbers.

Group 1 (SB2): Etched with 35% phosphoric acid gel for 30 s, rinsed and dried. Adper Single Bond 2 (3M ESPE St. Paul MN. USA) applied and light cured for 10s with a LED device (Demi Plus; Kerr, Switzerland) Group 2 (SBU-ER) : Etched with 35% phosphoric acid gel for 30s, rinsed and dried. Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied, gently air thinned for 5 s and light cured for 10s with a LED device Group 3 (SBU-SE): Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied for 20 s with vigorous agitation, gently air thinned for 5 s and light cured for 10 s with a LED device A nanofilled fissure sealant, Fissurit FX (Voco,Cuxhaven,Germany) was applied to the fissures and air entrapment was prevented by carefull spreading with a dental probe. The sealant material was light-cured for 20 seconds with LED. The occlusion was checked with articulating paper. Fine-grit diamond burs (Diatech, Swiss Dental, Switzerland) and rubber cups (Edenta AG, AU SG, Switzerland). were used for finishing and polishing.

Each restoration was evaluated at baseline,1week after treatment and 6, 12, 18 and 24 months. Evaluation of restorations was carried out by two calibrated examiners who were unaware of group allocation and who were not involved with the treatment procedures, by the help of a mirror, blunt explorer and air stream. Caries formation was evaluated as present or absent and the sealants were evaluated according to the following criteria: 1= Completely retained 2= Partial loss 3= Total loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 22 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.

排除标准

  • bad oral health, maloclusion, allergy to resins used

结局指标

主要结局

The evaluation of retention rate of fissure sealants

时间窗: 24 month

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Emel Karaman

associate professor

Ondokuz Mayıs University

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