Comparative evaluation of clinical success of stainless steel and Kids-e- Bioflex crowns in primary teeth – A split mouth prospective randomized clinical study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary outcome is the success of the treatment. Success will be defined by the absence of major failure fracture, wear, color change
研究概览
简要总结
Dentalcaries is an infectious transmittable bacterial disease, which is characterizedby a multi-factorial pathology.1 In the early childhood the caries(ECC) have effects on both dental and general health of the child.2Oral 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
Inorder to preserve the functional integrity of primary dentition, it isimportant to perform different restorative treatment due to an increase in theprevalence of dental caries today.6 In all restorative procedures,there is a loss of some amount of tooth structure, these damaged teeth can berestored with various restorative materials such as resin modified glassionomer cement, resin filled composite or resin filled composite.7 Forprimary molar teeth, preformed metal crown were first described by Engle8in year 1950 and followed by Humphrey.9 Since then, crown designmodifications are done, to improve morphology of crown and to simplify thefitting procedure.10 Stainless steel crowns are the first choice forrestoring defects due to caries in primary dentition and the most reliable andsuccessful form of tooth restoration is in pediatric dentistry.9Stainless steel crown placement is easy and economical with a high success ratefor preserving remaining teeth damaged by excessive preparation.11,12Esthetic concern is reported to be the most important problem for dentalrestoration in a study in pediatric patients.13Accordingly, newmaterials have been created to replace SSCs, such as bonded strip crowns,open-faced crowns and pre-veneered SSCs.14,15 These new materialshave enhanced aesthetics but have side effects such as poor gingival health anddental margin exposure due to metal presence.11 In particularpre-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 variousoptions like preformed zirconia crowns for esthetic concern. Based ontechnical, functional and esthetic limitations, each technique is associatedwith the own sets of advantages and disadvantages.17, 18, 19
Alternative to these, prefabricated estheticflexible crowns are comparatively new. Flexible crowns allow practitioner toprovide aesthetics of new age crowns and easy, economical as well asconservative preparation of stainless steel crowns in addition to that they can be corrected like SSCs and that’sthe reason this study is planned
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 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.
- •Medically free patients or with controlled systemic disease ASA I or II.
- •No active periodontal diseases.
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.
- •Presence of malocclusion like cross bite, crowding, scissor bite etc.
- •Child allergic to local anesthesia, chromium, or nickel.
结局指标
主要结局
The primary outcome is the success of the treatment. Success will be defined by the absence of major failure fracture, wear, color change
时间窗: one year
Duration, occlusion, gingival margin extension and parent
时间窗: one year
acceptance will be clinically evaluated at baseline and at last appointment
时间窗: one year
次要结局
- The secondary outcomes are parental and child satisfaction (size, form, and function), retention and fracture of the crown.(The wear of the antagonist tooth will be recorded.)