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临床试验/CTRI/2023/08/056863
CTRI/2023/08/056863尚未招募Unknown

Comparative evaluation of shear bond strength of different orthodontic brackets bonded with two different colour change orthodontic adhesives on fluorosed teeth.

Kalka Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年4月9日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To compare the shear bond strength of self-ligating brackets (metal & ceramic) & conventional bracket (metal & ceramic) which are bonded on fluorosed teeth

研究概览

简要总结

The success of orthodontictreatment relies on the bonding of brackets to enamel. However, bracket bondingfailure is a common issue, especially when bonding on fluorosed enamel, whichis more porous and hypomineralized. Fluorosed enamel contains acid-resistantcrystals and a higher protein content, compromising bonding. Alternativetreatments are proposed to improve bracket retention, such as intraoral sandblastingto increase surface roughness or deproteinization using sodium hypochlorite(NaOCl) to remove organic elements. The conversion of resin cement into apolymer is also important for successful bonding.

AIM AND OBJECTIVESAIM

The aim of thisstudy is to compare the shear bond strength of self-ligating brackets (metal& ceramic) and conventional bracket (metal & ceramic) which are bondedon fluorosed teeth.

OBJECTIVESTo investigate the effect of fluorosis on shear bond strength,etching time, adhesive remnant index score (ARI) when bonding differentorthodontic brackets on fluorosed enamel.

METHODOLOGY

·     The sample consisted of 44human fluorosed extracted for orthodontic purposes. Teeth were stored informalin until bonding procedures.

·     The sample size (n = 44) wasestimated with power analysis to provide statistical significance alpha = 0.05at an 80% power.

·     44 fluorosed teeth were dividedinto 4 groups of 11 each and bonded with different brackets.

·     Before bonding, the facialsurfaces of the teeth were cleaned with a mixture of water and pumice.

·     The teeth were rinsedthoroughly with water and dried with compressed air.

·     Each tooth is etched with 37%phosphoric acid gel for 30 seconds. Then, all teeth will be rinsed withwater/spray combination for 30 seconds and dried.

·     Polymerization of the bondingagent will be performed with a conventional LED curing light for 15 seconds forceramic brackets and 20 seconds for metal brackets.

·     Before determining the shearbond strength  and subsequent debonding,bonded teeth are stored in distilled water for 24 hours.

·     The shear bond strength testswill be performed at a crosshead speed of 1 mm/min during debonding. Theshearing debonding force is directed occluso-gingivally and recorded in MPa.Bond strengths were compared by ANOVA test.

·     A stereomicroscope at amagnification of 20x will be used to assess the amount of adhesive remaining onthe teeth and the brackets after debonding and will be scored according to theadhesive remnant index (ARI).

·     If deemed, necessary changeswill be made in the best interest of the study.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
5.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Extracted premolar for orthodontic treatment 2.Mild to moderate fluorosis 3.4 different brackets are used for checking the bond strength 4.LED Light cure unit.

排除标准

  • 1.Excessive caries 2.Excessive attritted teeth 3.Fractured tooth 4.Teeth with abnormal morphology.

结局指标

主要结局

To compare the shear bond strength of self-ligating brackets (metal & ceramic) & conventional bracket (metal & ceramic) which are bonded on fluorosed teeth

时间窗: 8 weeks

次要结局

  • To compare the shear bond strength of self-ligating brackets (metal & ceramic) & conventional bracket (metal & ceramic) which are bonded on fluorosed teeth(4 weeks)

研究者

发起方
Kalka Dental College and Hospital
申办方类型
Private medical college

研究点 (1)

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