Comparative evaluation of Silver Diamine Fluoride (SDF) and Universal Bonding Agent (UBA) in reducing dental caries and dental hypersensitivity in cariously affected (ICDAS 1-4) Molar Incisor Hypoplastic (MIH) permanent molar teeth.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Assessing dental hypersensitivity: (Schiff Cold Air Sensitivity Scale (SCASS) and / or VAS scores will used to assess the presence of hypersensitivity).
研究概览
简要总结
The study is a Randomized, Parallel GroupTrial Evaluating and comparing two agents namely- Silver Diamine Fluoride (SDF)and Universal Bonding Agent (UBA) in reducing dental caries and dentalhypersensitivity in decayed hypoplastic (weak) permanent molar teeth. Bothagents shall be applied in children aged 6- 14 years in MIH teeth with ICDAS scores1-4. Participant and Outcome Assessor Blinded and same children will beassessed for continuation/ arrest of dental caries and dentinalhypersensitivity at regular intervals of 3 weeks, 3 months, 6 months and 9months. The primary outcome measures of the study are caries arrest, assessedby changes in color and texture, and a decrease in dental hypersensitivitymeasured by predefined SCASS and VAS scores.
The results indicated that out of 243teeth, 212 teeth (111 belonging to the SDF group and 101 belonging to the UBAgroup) were available for follow-up at the end of the 9-month follow-up period.The ICDAS categorization and Schiff Cold Air Sensitivity Scale (SCASS) of theavailable 212 teeth were recorded. The study also included intra- andinter-group comparison of both agents pre-operatively and post-operatively at 9months, which was summarized. The statistical analysis showed no statisticallysignificant reduction in the ICDAS scores for both the SDF and UBA groups.However, there was a statistically significant reduction in the sensitivityscore (Schiff score) between the pre- and post-values for both the SDF and UBAgroups.
The rate of reduction between the studygroups showed no statistical difference, indicating that both had a similareffect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •children aged 6- 14 years of age MIH teeth with ICDAS- 2 score containing first digit 0, second digit scores of 1-4.
排除标准
- •Teeth that have undergone any kind of restoration coded as per ICDAS restoration/ sealant code 1 to 9 (first digit)
- •history of spontaneous or elicited pain from caries.
- •pathological tooth mobility
- •signs of pulpal infection
- •children with severe medical conditions.
- •hereditary developmental defects like amelogenesis imperfecta or dentinogenesis imprefecta.
- •teeth with fluorotic hypoplasia
- •known allergies or sensitivities to dental materials used in the study (like SDF/ UBA)
- •definitely uncooperative children (Frankl definitely negative).
结局指标
主要结局
Assessing dental hypersensitivity: (Schiff Cold Air Sensitivity Scale (SCASS) and / or VAS scores will used to assess the presence of hypersensitivity).
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
Positive outcomes – Improvement in SCASS and / or VAS scores
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
Negative outcomes- No improvement or worsening of SCASS and / or VAS scores
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
Assessing for caries arrest:
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
Positive outcomes - Dark, hard, and black lesions with no pain or infection
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
Negative outcomes -Progression of the lesion, a yellow, brown, soft lesion with or without pain or infection.
时间窗: Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months
次要结局
- aesthetic outcome: Likert-scale questionnaire shall be used in children to know outcome.(Children shall be followed-up and re-evaluated using ICDAS-2 scale after 3 weeks, 3 months and 6 months)