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临床试验/CTRI/2024/10/075519
CTRI/2024/10/075519尚未招募3 期

Comparative Evaluation of Retention of Moisture Tolerant Pit and Fissure Sealant with Hydrophobic Sealant on Newly Erupted Permanent Molars – A Randomized Controlled Clinical Trial

Institute ITS Dental College and Research Centre1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
• Ultraseal XT Hydro is expected to show superiority over the hydrophobic sealant in terms of sealant retention and caries inhibition when evaluated over 3, 6 and 12 months.

研究概览

简要总结

Pit and fissure sealants play a crucial role in preventing newly erupted molars from getting cariously involved. Since sealants bond micro mechanically to the tooth surface, therefore sealant adhesion is drastically influenced by the isolation achieved during the placement of these resin based materials. in such a scenario, novel hydrophilic sealants offer a great advantage since they are water miscible and thixotropic and can be placed with high clinical efficiency in paediatric patients where it is impossible to achieve complete moisture control. Hence the aim of this split mouth randomised controlled clinical trial is to compare and evaluate the retention of hydrophilic sealants with hydrophobic sealants when applied on newly erupted permanent molars. For this study, 34 participants between 6-14 years of age will be selected. Two teeth from each participant (one each on right and left side of the mouth) will be selected and randomly allocated into two groups : in group A the teeth will be sealed with Ultraseal XT Hydro (hydrophilic sealant), in group B the teeth will be sealed with Voco Fissurit F (Hydrophobic sealant). Evidence of new caries and sealant retention will be assessed at 3, 6 and 12 months. The results will be subjected to statistical analysis.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant 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

  • Cooperative children between 6-14 years
  • Healthy patients with no history of previous systematic diseases that can affect their oral health (ASA I, II)
  • At least two fully erupted permanent molars (one on each side: right and left)
  • Permanent molars’ occlusal surfaces show scores of 0 or 1 according to the International Caries Detection and Assessment System II (ICDAS II).

排除标准

  • Uncooperative children
  • Parents or guardians from whom consent cannot be obtained.

结局指标

主要结局

• Ultraseal XT Hydro is expected to show superiority over the hydrophobic sealant in terms of sealant retention and caries inhibition when evaluated over 3, 6 and 12 months.

时间窗: At baseline, 3 months, 6 months and 12 months.

次要结局

  • Sealant retention, evidence of new caries(3months, 6months, 12 months)

研究者

发起方
Institute ITS Dental College and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sahin Firdous Ahmed

I.T.S Dental College, Hospital and Research Centre, Knowledge Park 3, Greater Noida

研究点 (1)

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