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临床试验/CTRI/2024/04/065009
CTRI/2024/04/065009尚未招募1/2 期

Comparative evaluation of the effectiveness of Silver-modified atraumatic restorative technique (SMART) with Atraumatic restorative treatment (ART) on management of dental caries among 5 years old School children: A Randomised Controlled Trial.

Saniya Shaikh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1. To compare SMART with ART on management of dental caries assessed

研究概览

简要总结

The data collection procedure will be as follows: - Participants fulfilling the inclusion criteria will be selected. At Baseline Demographic Details of the participants and Informed consent from parents or guardians will be taken. ICDAS Score of the tooth (D and/or E) will be recorded. Using Coin Toss Method, one side of the Oral Cavity will be subjected to SMART and other side will be subjected to ART. Isolation of tooth with the help of Cotton rolls and Excavation of the soft caries with spoon excavator will be done. Group A (SMART)- 38% SDF will be applied directly to the lesion with an applicator tip, left for 2 minutes, and restored with GIC. Group B (ART)- Cavity will be filled with GIC and with the help of finger-press technique excessive restorative material along the slopes of the cusps will be removed. At Follow up At 1, 3 and 6 Months the teeth will be assessed using USPHS Criteria32 (Annexure VI) and ART restoration criteria33 (Annexure VII) -If there is any dislodgement/ fracture of the restorative material and observance of secondary caries under the restoration the participant will be excluded after re-restoring the tooth.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Participants of age group 5 years old.
  • Parents/caregivers of the children who are willing to participate in the study and give informed consent.
  • Caries present as per International Caries Detection and Assessment System (ICDAS)31 (Annexure V) code 3 & 4 in deciduous molar (D & E) bilaterally in maxillary and/or mandibular arch.
  • Caries involving occlusal surface only.

排除标准

  • Participants showing uncooperative behaviour.
  • Participants who will not be present at the time of the study.
  • Participants with proximal and multi surface dental caries.
  • Participants with designated primary molars having existing restorations.
  • Participants with designated molars having deep carious lesions with close proximity to the pulp.

结局指标

主要结局

1. To compare SMART with ART on management of dental caries assessed

时间窗: 3 months

using Modified US Public Health Service Criteria (USPHS) Criteria and ART

时间窗: 3 months

restoration criteria

时间窗: 3 months

次要结局

  • Reduce Dental caries progression(3 months)

研究者

发起方
Saniya Shaikh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Saniya Shaikh

sinhgad Dental College and Hospital Pune

研究点 (1)

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