Clinical evaluation of effect of sonic vibration and fissurotomy on retention and marginal integrity of pit and fissure sealants reinforced with silver nanoparticles - A 1yr follow up study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effect of sonic vibration and fissurotomy on retention and marginal integrity of silver nanoparticle reinforced pit and fissure sealants.
研究概览
简要总结
The incidence of dental caries in India affects around 60-80% of children. Pit and fissure sealants reduce this by 70-90%, effectively sealing vulnerable areas on teeth, preventing food particles and bacteria from accumulating and causing decay, thereby promoting better oral health. However, the success of sealants depends significantly on their ability to adhere to enamel surfaces and maintain marginal integrity over time. Various techniques and materials have been explored to enhance sealant retention and effectiveness. This study focuses on evaluating the impact of sonic vibration and fissurotomy on the retention and marginal integrity of pit and fissure sealants, specifically those reinforced with silver nanoparticles.Sample Size and Study Design: The study will involve a total of 176 permanent first molars in children aged 6-9 years. A randomized controlled split-mouth design will be employed, dividing the teeth into four groups:
- Group A (Control): In this group, the conventional method of sealant application will be used.
- Group B: Sealants will be applied with the assistance of sonic vibration using a Compo-vibes device.
- Group C: Enamel preparation will involve the use of a Micro STF fissurotomy bur followed by conventional sealant application.
- Group D: Enamel preparation with a Micro STF fissurotomy bur will be combined with sealant application assisted by sonic vibration.
Materials and Armamentarium: The study will utilize standard dental examination tools such as mouth mirrors, tweezers, probes, and explorers for clinical assessments. A rubber dam isolation kit will ensure effective isolation during procedures. Enamel preparation will be carried out using a 35% phosphoric acid etchant, and sealants used will be specifically e-Pit and fissure sealant reinforced with silver nanoparticles. Curing of sealants will be conducted with a light curing unit featuring appropriate wavelength and intensity. Specialized instruments like the Compo-vibes composite modeling instrument and Micro STF fissurotomy bur will be employed for sonic vibration and fissurotomy procedures, respectively.
Procedure: Each group will undergo a specific sequence of procedures tailored to their assigned technique:
- Group A (Control): The teeth will be etched with 35% phosphoric acid, followed by application and curing of the e-Pit and fissure sealant.
- Group B: Enamel etching will be performed with simultaneous sonic vibration using the Compo-vibes device, followed by sealant application and curing.
- Group C: Enamel preparation will involve the use of the Micro STF fissurotomy bur to mechanically widen fissures, followed by standard etching, sealant application, and curing.
- Group D: Similar to Group C, enamel preparation with the Micro STF fissurotomy bur will be combined with etching assisted by sonic vibration using the Compo-vibes device, followed by sealant application and curing.
Evaluation Criteria: The modified United States Public Health Service (USPHS) Ryge criteria will be employed to assess:
- Sealant retention: This criterion evaluates partial or total loss of sealant over specified time intervals (3, 6, 9, and 12 months).
- Marginal integrity: This criterion assesses the quality of sealant adaptation to enamel margins, ensuring effective coverage and sealing of fissures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged between 6 to 9 years falling under Frankl’s behavior rating scale criteria 3 and
- •All four permanent molars erupted.
- •Molars with no developmental abnormalities.
- •Teeth with ICDAS score 0 6) Children whose parents gave consent to participate in the study.
排除标准
- •Teeth with sealants and fillings.
- •Teeth with caries.
- •Children with stain on grooves.
- •Children falling under Frankl’s behavior rating scale criteria 1 and
- •Teeth with developmental abnormalities.
结局指标
主要结局
To evaluate and compare the effect of sonic vibration and fissurotomy on retention and marginal integrity of silver nanoparticle reinforced pit and fissure sealants.
时间窗: 3 moths, 6 months, 9 months, 12 months
次要结局
- To assess & compare the retention of pit & fissure sealant using sonic vibration, fissurotomy, fissurotomy along with vibration & conventional technique.
研究者
Darshana S
SRM Ramapuram
