Comparative Assessment of Retention and Discoloration of Pit and Fissure Sealants in Children - In vivo study.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retention rate of pit and fissure sealants on all four permanent first molars, assessed at periodic intervals (3,6 months) using standardized retention criteria (fully retained, partially lost, completely lost).
研究概览
简要总结
This in vivo study aims to evaluate the retention and discoloration of different pit and fissure sealants applied on all four permanent first molars in children aged 7–15 years. A total of eligible participants will be recruited based on strict inclusion and exclusion criteria, ensuring teeth are sound, vital, and free of cavitated lesions or previous restorations. Sealants will be placed under standardized clinical conditions and evaluated at predetermined time points (3, 6 months ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 7–15 years with mixed dentition.
- •Presence of all four fully/partially erupted permanent first molars suitable for sealant placement.
- •Molars with deep pits and fissures or ICDAS 0–2 non-cavitated lesions, but without cavitation or restorations.
- •Clinically and radiographically sound teeth – vital, asymptomatic, and free from proximal dentinal caries.
- •Medically healthy, cooperative children with parental consent and willingness for follow-up visits.
排除标准
- •Children with systemic illnesses, special healthcare needs, or developmental enamel/dentin defects (e.g., MIH, fluorosis).
- •Permanent first molars with cavitated caries, restorations, hypoplasia, or previous sealant application.
- •Teeth with pulpal symptoms, periapical pathology, or radiographic evidence of dentinal/proximal caries.
- •Children unable to maintain adequate isolation or moisture control during sealant placement.
- •Uncooperative children or those without parental consent/follow-up compliance.
结局指标
主要结局
Retention rate of pit and fissure sealants on all four permanent first molars, assessed at periodic intervals (3,6 months) using standardized retention criteria (fully retained, partially lost, completely lost).
时间窗: 3,6 , 12 months
Discoloration of sealants, evaluated clinically by visual comparison with baseline shade (using a standardized shade guide or scoring system) at the same follow-up intervals.
时间窗: 3,6 , 12 months
次要结局
- Marginal integrity and surface wear of the sealants, evaluated clinically using modified USPHS/FDI criteria at each follow-up.
研究者
Rasika Pavan Chandak
Saveetha dental college