Split Mouth Clinical Trial of Fissure Sealant Retention With Self Etching and Total Etch Bonding Agent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in retention of sealants from baseline to two years
研究概览
简要总结
The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months.Twenty-four subjects with no restoration and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a table of random numbers. Two other calibrated examiners, independently evaluated the sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period.
详细描述
Dental caries, which can be encountered by individuals throughout their lives, is one of the most chronic diseases worldwide. Researches have mainly been focusing on the prevention of tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure sealants are the most common preventive applications against caries progression.Modern adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols. However, it is still suspicious whether modern self-etch adhesives have equal bonding capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary to evaluate long-term adhesive performance of self-etch adhesives compared to the conventional etch-and-rinse ones.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who participated in the current study had good general and oral health and hygiene.
- •with no detecatable caries, bruxism, malocclusion, previously placed restorations or sealants on the fissures, or no allergies to resins
- •willing to return for follow-up examinations
排除标准
- •Third molars
- •Uncooperative patients
- •Molar teeth with antagonist tooth not present or extracted
- •Mentally and physically handicapped patients
结局指标
主要结局
Changes in retention of sealants from baseline to two years
时间窗: at baseline and at 6-, 12-, 18-, and 24-month
The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every 6 month for 2 years.
次要结局
未报告次要终点
研究者
Zeynep Bilge Kutuk
Research assistant
Hacettepe University