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临床试验/CTRI/2022/12/048617
CTRI/2022/12/048617招募中不适用

Comparative evaluation of clinical and radiographic success after placement of preformed stainless steel and flexible esthetic crowns by various techniques in pediatric patients – A parallel group prospective randomized clinical study.

Dr Amol Patil1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
appointment

研究概览

简要总结

Dental caries is an infectious transmittable bacterial disease, which is characterized by a multi-factorial pathology.1 In the early childhood the caries (ECC) have effects on both dental and general health of the child.2 Oral health impacts on the quality of life of children 3, 4. However, extreme caries have a noticeable impact on the diameter of the arch.5

In order to preserve the functional integrity of primary dentition, it is important to perform different restorative treatment due to an increase in the prevalence of dental caries today.6 In all restorative procedures, there is a loss of some amount of tooth structure, these damaged teeth can be restored with various restorative materials such as resin modified glass ionomer cement, resin filled composite or resin filled composite.7 For primary molar teeth, preformed metal crown were first described by Engle8 in year 1950 and followed by Humphrey.9 Since then, crown design modifications are done, to improve morphology of crown and to simplify the fitting procedure.10 Stainless steel crowns are the first choice for restoring defects due to caries in primary dentition and the most reliable and successful form of tooth restoration is in pediatric dentistry.9 Stainless steel crown placement is easy and economical with a high success rate for preserving remaining teeth damaged by excessive preparation.11,12 Esthetic concern is reported to be the most important problem for dental restoration in a study in pediatric patients.13Accordingly, new materials have been created to replace SSCs, such as bonded strip crowns, open-faced crowns and pre-veneered SSCs.14,15 These new materials have enhanced aesthetics but have side effects such as poor gingival health and dental margin exposure due to metal presence.11 In particular pre-veneered SSC veneer resin sometimes chips and results in additional care..15,16

Today, for the restoration of the primary teeth, the dental practitioner has various options like preformed zirconia crowns for esthetic concern. Based on technical, functional and esthetic limitations, each technique is associated with the own sets of advantages and disadvantages.17, 18, 19

Alternative to these, prefabricated esthetic flexible crowns are comparatively new. Flexible crowns allow practitioner to provide aesthetics of new age crowns and easy, economical as well as conservative preparation of stainless steel crowns in addition to that  they can be corrected like SSCs and that’s the reason this study is planned

 In recent years restoring carious or fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance.

Treatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn’t require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.

But this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension.

 Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of preformed stainless steel and flexible esthetic crowns

 The purpose of this study is to compare the effectiveness of the flexible esthetic crown to the conventional Stainless-Steel Crown restoration by various techniques in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients and parents of the patients who accept to participate and sign the informed consent Primary teeth indicated for full coverage restoration.
  • Frankel’s positive and definitely positive patients Children aged between 4 to 10 years.
  • No significant medical history.
  • Patients willing to return for follow-up examinations and evaluation.
  • No active periodontal diseases.

排除标准

  • Patients and parents of the patients who do not accept to participate and sign the informed consent Patients with a systemic disease, Teeth which have a short period of time for succedaneous teeth to erupt Any subject that does not fall under the inclusion criteria were excluded Children with special needs.
  • Presence of malocclusion like cross bite, crowding, scissor bite etc.
  • Lived in remote villages and were unlikely to return for follow-up Patients with TMJ abnormalities.

结局指标

主要结局

appointment

时间窗: 12 months

The primary outcome is the success of the treatment. Success

时间窗: 12 months

will be defined by the absence of major failure

时间窗: 12 months

acceptance will be clinically evaluated at baseline and at last

时间窗: 12 months

fracture, wear, color change

时间窗: 12 months

Duration, occlusion, gingival margin extension and parent

时间窗: 12 months

次要结局

  • The secondary outcomes are parental and child satisfaction (size, form, and function), retention and fracture of the crown.(. Finally, the wear of the antagonist tooth will be recorded (0: absence of wear; 1: wear on only the cusp point; and 2: wear at least at the cusps) reference. To prevent information bias, the evaluators will not be the operators who applied the treatment.)

研究者

发起方
Dr Amol Patil
申办方类型
Other [self]

研究点 (1)

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