"Comparative Evaluation of Clinical Success of Zirconia Crowns and Esthetic Flexible Crowns in Primary Teeth – A Parallel Group Prospective Randomized Clinical Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amol Patil
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome is the success of the treatment. Success
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
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
- •Parents willing to give 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.
- •Each selected tooth must have an antagonist tooth present.
排除标准
- •Any subject that does not fall under the inclusion criteria were excluded Parents not willing to give consent.
- •Children below the age of 4 and above the age of
- •Children with special needs.
- •Inadequate root length.
- •Child allergic to local anesthesia, chromium, or nickel Severely decayed tooth prohibiting the retention and the sealing of the restoration Tooth with evidence of swelling in the surrounding tissues Tooth in infra-occlusion Presence of malocclusion like cross bite, crowding, scissor bite etc.
结局指标
主要结局
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
fracture, wear, color change
时间窗: 12 months
Duration, occlusion, gingival margin extension and parent
时间窗: 12 months
acceptance will be clinically evaluated at baseline and at last
时间窗: 12 months
appointment
时间窗: 12 months
次要结局
- The secondary outcomes are parental and child(satisfaction (size, form, and function), retention)