The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars: a 2-year Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Sealant Retention
研究概览
简要总结
Background: Resin-based fissure sealants (FS) are recommended to prevent pit-and-fissure caries development or prevent the progression of enamel caries lesion to frank cavitation into dentine. There is still limited clinical evidence on the use of adhesive system beneath fissure sealants in permanent molars and its effect on FS retention and caries progression.
Aim: The aim of this randomised clinical trial is to evaluate the clinical efficacy of fissure sealants placed with and without prior use of an adhesive system in terms of retention and caries prevention in permanent molars over the period of 2 years.
Study design: Children (6-12 years of age) with high caries risk that require sealants in their first permanent molars (ICDAS 0-3) will be selected at the Dublin Dental University Hospital (DDUH). Molars will be stratified according to presence of caries lesions (ICDAS 0 or ICDAS1-3) and randomly allocated according to the study groups (Test group: 17% phosphoric acid + adhesive system + FS; Control group: 17% phosphoric acid + FS). The randomisation unit will be the tooth and more than one tooth can be included per child. All children will be evaluated after 12 and 24 months by calibrated independent examiners. The primary outcome of the present trial is sealant retention over time. Clinical variables such as age, gender, tooth position (upper/lower), caries experience (DMFT/dmft), stage of eruption (erupted/partially erupted) and children's behavior (Frankl scale) will be collected.
详细描述
Introduction
Resin-based fissure sealants (FS) have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars. Several international guidelines recommend the use of FS for caries prevention in the paediatric population.
The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface. Resin based-fissure sealants contain light-activated urethane dimethacrylate (UDMA) or bisphenol A-glycidyl methacrylate (Bis-GMA) resin in its composition which bonds to the etched enamel. Several clinical studies have investigated the use of an intermediate layer of adhesive system (primer and bond) in order to increase the bonding strength and increase retention of FS over time in caries free molars, however little is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions.
Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination (poor moisture control) during application. Therefore, the stage of eruption, patient's behaviour and operator experience can play a major role when it comes to FS retention on tooth surfaces. The majority of clinical trials in the field had trained and experienced operators, including specialists in paediatric dentistry, which could impact the translational and external validity of their findings. More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in different environments.
Therefore, the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time.
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, Outcomes Assessor)
盲法说明
Outcome assessor (independent examiner) and participants will be blind to study groups.
It is not possible to blind the operator due to differences in material capsule colours/consistency at the time of fissure sealant placement.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 to 12 years of age;
- •Referred for dental treatment at the Dublin Dental University Hospital DDUH) or that are ongoing patients of the Paediatric dentistry clinic;
- •With first permanent molars that are caries free or present caries lesions restricted to enamel (ICDAS 1 to 3) indicated for glass ionomer sealants.
- •Whose parents agreed and consent to participate in the present research;
排除标准
- •Presence of any developmental defects
- •Presence of any type of restorative/sealant material in the selected tooth;
- •Presence of a dentine shadow (ICDAS 4) or dentine cavitation (ICDAS 5/6) detected clinically and/or radiographically14;
- •Insufficient cooperation to achieve adequate moisture control using cotton roll isolation
研究组 & 干预措施
Fissure sealant with adhesive system (BOND)
Teeth randomised to the test group will be treated using fissure sealant with adhesive system (BOND)
干预措施: Fissure sealant with adhesive system (BOND) (Procedure)
Fissure sealant without adhesive system (NO BOND)
Teeth randomised to the control group will be using issure sealant without adhesive system (NO BOND)
干预措施: Fissure sealant without adhesive system (NO BOND) (Procedure)
结局指标
主要结局
Sealant Retention
时间窗: Sealant retention will be evaluated after 1 and 2 years.
Sealant retention will be examined after 1 and 2 years by a trained, calibrated, independent examiner. Sealant retention (secondary outcome) will be evaluated according to the scoring system proposed by Oba et al. 2009: 0 (fully retained sealant); 1 (partially retained sealant) or 2 (absent sealant). Early failures will be identified and recorded in the patient's review appointment in the undergraduate clinic.
次要结局
- Caries Progression(Caries Progression will be evaluated after 1 and 2 years)
- Patient behaviour(Immediately after the procedure)
研究者
Rona Leith
Assistant Professor
University of Dublin, Trinity College