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临床试验/CTRI/2025/07/091035
CTRI/2025/07/091035尚未招募不适用

Comparative evaluation of high viscocity glass ionomer based sealant and resin based sealant on permanent molars in children: An invivo study.

Dr Shilpashree S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
to evaluate and compare the clinical effectiveness of high-viscosity glass ionomer-based and resin based sealants in terms of retention, marginal adaptation and caries prevention on permanent molars in children.

研究概览

简要总结

Sixty permanent molars from children aged 6-12 years, who visits The Department of Pediatric and Preventive Dentistry at The Oxford Dental College and meet the inclusion criteria, will be selected for the study. The selected children will be assigned to two groups, with 30 permanent molars in each group.

Group 1: High viscocity glass ionomer based sealant.

Group 2: Resin based sealant.

The split mouth design will be chosen for 30 patients to compare two sealants, the high viscocity glass ionomer sealant, (IonoStar® Plus**,** VOCO) will be applied on permanent molar in one quadrant and the resin based sealant (Helioseal® F Plus, Ivoclar vivadent) on the contralateral side of the permanent molar as per the manufacturer’s instructions.

Prior to the application of sealant, the scaling procedure will be carried out, followed by prophylaxis using slurry of pumice and a rotating brush to ensure removal of plaque and debris from the enamel surfaces and fissures. ICDAS II scores will be assessed. Tooth will be isolated using minidam technique as per the manufacturer’s instructions(DMG).

The glass ionomer sealant material [Group 1] is available as capsules. The sealant is applied on the occlusal surface of the teeth following manufacturer’s instructions. The capsule must only be activated directly before use and loaded immediately into a high frequency amalgamator and mixed for 10 seconds. Capsule is removed from the mixer without delay and inserted in the holder of an application device, apply the material directly into the cavity within 10 seconds of the end of mixing by compressing the lever on the applicator slowly and evenly. Sealant can be worked for at least 1minute, material will be prevented from moisture contamination and protective varnish will be applied after the contours have been finished.

Similarly, the occlusal surface of the teeth in the contralateral side will be etched with 37% phosphoric acid for 15-30 seconds, rinsed thoroughly with water, air-dried for 5 seconds until a chalky-white enamel surface will be visible, followed by the application of [Group 2] resin based sealant to the fissure pattern by distributing with dental probe, prevent air bubbles from getting incorporated. It is then light cured for 10-20 seconds.

An explorer will be used to check complete coverage of pit and fissures of first permanent molars. The set sealants should be checked for high points with an articulating paper and if present, will be reduced with a finishing bur.

Patient will be instructed not to eat for at least one hour after the procedure.

The follow up examinations will be conducted at first, third, sixth and twelve months. At each recall visit, Modified United States Public Health Service (USPHS)/Modified Ryge criteriawill be used to check for the retention and marginal adaptation of sealants using Community Periodontal Index of Treatment Needs (CPITN) probe. In case of sealant loss, ICDAS II will be used to check for caries.

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 12.00 Year(s)(—)
性别
All

入选标准

  • Healthy cooperative children with fully erupted permanent molars between the age of 6 to 12 years.
  • Deep pits and fissures are present in these permanent molars ICDAS II code
  • Initial occlusal carious lesions involving the pits and fissures of enamel ICDAS II code
  • Incipient carious lesion involving enamel ICDAS II code 02 and 03.

排除标准

  • • Children whose parents did not give consent for the study.
  • • Medically compromised children.
  • • Children with enamel hypoplasia or any developmental anomalies.

结局指标

主要结局

to evaluate and compare the clinical effectiveness of high-viscosity glass ionomer-based and resin based sealants in terms of retention, marginal adaptation and caries prevention on permanent molars in children.

时间窗: Baseline- 4weeks | followup- 1month, 3month, 6month and 12 month

次要结局

未报告次要终点

研究者

发起方
Dr Shilpashree S
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

DR SHILPASHREE S

The Oxford Dental College Bangalore

研究点 (1)

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