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临床试验/CTRI/2026/02/102802
CTRI/2026/02/102802尚未招募2 期

Clinical evaluation of Light cured Glass Ionomer cement versus Resin-modified Glass Ionomer Cement in class V carious and non-carious lesions: A Randomized Comparative Study

mahatma Gandhi dental college jaipur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月12日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

For this study 50 patients with class V carious and non-carious lesion will be selected.

Fifty participants with class V carious and non-carious lesions will randomly be assigned to two

groups based on the restorative material used. The intervention group (Group 1) will receive light

cured GIC, and the control group (Group 2) will receive RMGIC.

The clinical performance will be assessed at baseline, after 6 and 12 months follow-up using the

modified United States Public Health Service (USPHS) criteria.

Recruited participants will be provided with comprehensive details about the study, after which they

will sign an informed consent .History taking, caries risk assessment, and dental examination will be

done. Prophylactic scaling and polishing will be carried out for all eligible participants. Any dental

concerns were addressed before the start of the trial.

A conservative cavity design will be prepared using round shaped carbide burs with sharp dental

excavators to remove soft carious dentin. The prepared cavity was finished using yellow-coded,

extra-fine, and diamond finishing burs.

GROUP -1 (Light Cured Glass Ionomer Cement)

Selective enamel etching, thorough rinsing, and gentle air dryness were performed (OptiBond Gel

Etchant, Kerr Corporation, California, USA) followed by adhesive application. Light cured GIC (3M

Ketac N100 light-curing glass ionomer restorative) will be applied incrementally 2 mm into the

prepared cavity and sculpted using gold plated applicators. Each increment was light cured for 10 s.

using LED light curing unit (iLED plus, Guilin Woodpecker Medical Instrument Co. Ltd., Guangxi,

China).

GROUP -2 (Resin-Modified Glass Ionomer Cement)

Dentin conditioning was done using 10% polyacrylic acid for 20 s (Dentin Conditioner, GC

Corporation, Tokyo, Japan) followed by thorough rinsing and gentle air dryness. The was done with

resin modified gic (GC Fuji plus RM GIC, Tokyo, Japan) and mixed for 10 s, extruded into the

prepared cavity incrementally 2 mm using the capsule applier, sculpted using a gold plated applicator

Finishing and polishing.

For both groups, yellow-coded, extra-fine diamond finishing stones will be used for restoration

contouring and finishing followed by polishing using silicone cups and points till a smooth, lustrous

surface will be obtained. For the control group, a resin coat (Fuji coat LC, GC Corporation, Tokyo,

Japan) will applied on the restoration surface, and then light cured for 20 s.

After the restoration is done ,it will be evaluated for marginal adaptaion, marginal staining, surface

texture, secondary caries, retention and post operative sensitivity.

The marginal staining will be evaluated using 2% Methylene blue dye[4] at 6 months and 12 months

interval.

The dye penetration is checked at tooth-restoration interface under 6x magnification using

microscope.

The subjects’ responses will be evaluated by Schiff analog scale to assess postoperative sensitivity to

an air blast stimulus. It assigns scores ranging from 0 to 3 to participants. The scoring criteria for the

Schiff analog scale are the following:

Patients exhibiting pre-operative scores of 2 or 3 on the Schiff scale will be also incorporated into this

research.

Marginal Staining- The marginal staining will be evaluated using 2% Methylene blue dye.

The dye penetration is checked at tooth-restoration interface under 6x magnification using microscope.

Marginal Adaptation- Using DG-16 explorer.

The explorer gently moved along the crevice to check for marginal adaptation.

Surface Texture-

  1. Polished=0 using DG-16 explorer

  2. Gritty=1

  3. Course=2

Secondary Caries- Secondary caries will be evaluated using IOPA radiographs.

retention present or absent

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Class V lesions- carious or non-carious lesions Age group 18 to 40 years Pre-operative sensitivity scores of 2 or 3.

排除标准

  • Periodontally compromised Pulpal inflammation Presence of periapical radiolucency Patients allergic to resin material Habits of clenching and bruxism.

研究者

发起方
mahatma Gandhi dental college jaipur
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anusha Saxena

mahatma Gandhi dental college

研究点 (1)

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