Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars - A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- US Public Health Service (USPHS) modified criteria
研究概览
简要总结
Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM
详细描述
A split mouth trial was conducted among 36 children of age 6-8 years, in which Bioflx crowns (Kids-e-dental)TM and Stainless Steel crowns (Rainbow crowns)TM are placed in each primary molar in bilateral or contra-lateral sides. The clinical effectiveness is evaluated using US Public Health Service modified criteria at baseline and after 1,3,6 and 12 months. The parental satisfaction of restoration is recorded using a 5-point Likert scale at baseline and 12 months. Descriptive statistics and intra-group comparison were analyzed using Chi-square test, while intergroup comparison was analyzed using Mann-Whitney test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• At least two primary molars (contra-lateral or opposing side) needing full coverage restoration.
- •Consent of patient/legal guardian of the child
- •Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive)
排除标准
- •• Parent not willing to give consent.
- •Child with special health care needs
- •Uncooperative child based on Frankel rating1or 2 (definitely negative or negative)
- •History of Ni-Cr allergy
研究组 & 干预措施
BIOFLX crowns ( kids-e-dental)
Crowns placed
干预措施: US Public Health Service modified criteria (Procedure)
BIOFLX crowns ( kids-e-dental)
Crowns placed
干预措施: The parental satisfaction (Procedure)
Stainless steel crowns (Rainbow crowns)
Crowns
干预措施: US Public Health Service modified criteria (Procedure)
Stainless steel crowns (Rainbow crowns)
Crowns
干预措施: The parental satisfaction (Procedure)
结局指标
主要结局
US Public Health Service (USPHS) modified criteria
时间窗: 1st month, 3rd month, 6th month and 12 th month
The following variableswere assessed; retention, color match, marginal discoloration and adaptation, secondary caries, wear and post-operative sensitivity
次要结局
- The parental satisfaction(1st month and 12th month)
研究者
satish vishwanathaiah
Associate professor
University of Jazan