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
- 1
- 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
研究组 & 干预措施
acid-etch only
Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid-etch only will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
干预措施: acid-etch (Other)
self-etch adhesive
Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for self-etch adhesive will be treated with self-etch adhesive (AdperTM EasyBond, 3M ESPE) for 10 seconds followed by light curing for 20 seconds. Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
干预措施: self-etch adhesive (Other)
etch-and-rinse adhesive
Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for etch-and-rinse adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, etch-and-rinse adhesive (Single BondTM, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
干预措施: etch-and-rinse adhesive (Other)
self-etch adhesive after acid-etch
Selected teeth would receive prophylaxis with pumice using prophylaxis brushes for 20 seconds. The teeth will be isolated with cotton rolls before application of bonding agent. The tooth selected for acid etch + self-etch adhesive will be treated with 37% phosphoric acid for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe till frosty white appearance is achieved. Then, self-etch adhesive (AdperTM EasyBond, 3M ESPE) will be treated with for 10 seconds followed by light curing for 20 seconds.Clinpro(3M ESPE) fissure sealant will be applied to pits and fissures and then light cured for 20 seconds.
干预措施: self-etch adhesive after acid-etch (Other)
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