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临床试验/CTRI/2025/01/079196
CTRI/2025/01/079196尚未招募不适用

Comparative clinical evaluation of flexible crowns and strip crowns in primary anterior teeth: a 12-month randomized trial

Aditi Hagwane1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1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
Bioflx crown is superior aesthetically and in retention than the anterior strip crowns.

研究概览

简要总结

Early childhood caries (ECC) is a chronic multifactorial disorder which continues to be dominant in children, especially in families of low socioeconomic status. Early childhood caries is defined as the existence of one or more tooth decays (non-cavitated or cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary dentition of children under the age of six years. Severe early childhood caries (S-ECC) is a progressive carious form in children, categorized in accordance to the number of affected teeth and the age of patient. Providing care to children who are considered to be at risk from ECC, can be achieved by a specialist who received adequate training and has experience in treating children as well as disease process.

Primary incisors with large or multi-surface caries can be restored with resin composite strip crowns if there is sufficient tooth structure after removing all carious tissues. When remaining tooth structure is minimal and not enough for bonding, pre-veneered aesthetic crowns is a favorable solution. Stainless steel crowns with cosmetic facing have good aesthetics and good retention even with minimal remaining tooth structure. Moisture and hemorrhage control are not critical with these restorations which need minimal chair time and offer full coverage and protection. The findings indicate that stainless steel crowns (SSCs) are valued for durability and cost-effectiveness, but they may cause hypersensitivity. Resin composite strip crowns are used for the rehabilitation of the primary anterior teeth using the celluloid forms of the crowns and resin composite. For many years, Strip crowns had been considered as the most aesthetic option for the mutilated primary anterior teeth. But strip crowns are highly technique sensitive, which require proper moisture control during bonding and the placement of the crowns. This isolation is difficult to obtain in children oral cavity not only due to fewer technique and materials are available for isolation in children but also because children who require these belong to the younger age group and most difficult to manage in operatory.

As an alternative to all these crowns, a new prefabricated aesthetic flexible crowns, made up of hybrid polymer resin and which is Bis -GMA free and metal free high strength resin polymer has been introduced as Bioflx crowns. According to the manufacturers, they can withstand high compressive forces, and are highly durable. These flexible crowns allow the paediatric dental practitioner to provide aesthetics of new age crowns with easy manipulation, conservative preparation similar to stainless steel crowns. However, no clinical studies have yet been published looking at the clinical performance of these Bioflx crowns in the anterior region.

Thus, the main purpose of this prospective, randomized clinical study is to compare the clinical efficacy of aesthetic flexible composite crown (Bioflx crowns) with a commercially available anterior composite strip crowns. The null hypothesis is that there is no difference in the clinical performance of the two-crown types.

Therefore, this study will be conducted to compare and evaluate a clinical success of anterior aesthetic flexible crowns with anterior strip crowns in primary anterior teeth among children aged 3-6 years.

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 Blinded

入排标准

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

入选标准

  • Healthy three to six years old children Primary anterior teeth indicated for full coverage restoration Those having opposed anterior teeth Minimal of two surfaces of caries in the targeted teeth Patient with Early Childhood Caries as defined by AAPD, 2016 Cooperative patients who had behaviour rating positive or definitely positive followed the Frankl behaviour classification scale.

排除标准

  • Teeth with proximity to exfoliation and resorption of the root passed its half Presence of single surface caries not involving the proximal surfaces Teeth that have been subjected to trauma Anxiety and lack of cooperation which required treatment under general anaesthesia Bruxism Special health needs Presences of teeth wear on the opposing teeth, or absence of opposing.

结局指标

主要结局

Bioflx crown is superior aesthetically and in retention than the anterior strip crowns.

时间窗: Outcome will be analyzed at 1 week, 1month, 3months, 6 months, and 12 months.

次要结局

  • There might be chances of staining in strip crown and would be more technique sensitive than bioflx crown.

研究者

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

Aditi Hagwane

Pacific Dental College And Hospital, Debari, Udaipur 313024 Rajasthan India

研究点 (1)

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