Assessment of clinical efficacy, parental and child acceptance of prefabricated Bioflx crowns in primary molars.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. To assess the clinical efficacy of prefabricated bioflx crowns in primary molars using
研究概览
简要总结
| Twenty |
| five primary molars (upper/ lower) will be selected based on inclusion |
| criteria, to receive prefabricated bioflx crown (Kids-e-Dental, Mumbai, India).The |
| treatment procedure and nature of study will be explained to the parents of |
| the children and their prior written informed consent will be taken. A |
| questionnaire-type proforma will be used to record demographic information. |
The prefabricated bioflx crown will be selected as per mesio-distal width and manufacturer’s instruction manual. Following application of topical local anesthesia gel, gingival retraction cords will be placed and tooth preparation will be checked to ensure crown will be a snug fit and occlusal height will be checked after placement of the crown. The crown will be cemented using luting type 1 glass ionomer cement. Patients will be given post-operative instructions and the crowns will be evaluated at 1, 3 and 6 months respectively.
Clinical evaluation of the prefabricated crown will be done according to criteria given by United State Public Health Service (USPHS).The prefabricated bioflx crown will be evaluated for color, marginal integrity, crown retention, restoration failure and opposing tooth wear through visual inspection and tactile examination using a dental explorer. A blunt periodontal probe (William’s periodontal probe) will be used to assess gingival health (Leo and Silness 1963) and plaque accumulation will be assessed using plaque index (Silness and Leo 1964) around the margins of prefabricated crown. Smith and Knight (1984)tooth wear index will be used to assess tooth wear in opposite teeth. Parental acceptance of prefabricated bioflx crowns for size, color and shape will be evaluated using 5 point Likert scaleand child acceptance will be done by using 5 point Likert facial expression scale.
An occlusal force meter (GM 10 Nagano Keiki, Japan) will be used to measure the pre-operative and post-operative bite force by asking the child to bite on the gauge of an occlusal force meter as hard as possible without moving the head for 15 secs. Each child will be asked to sit in an upright position without head support and with Frankfort horizontal plane parallel to the floor. The bite force will be expressed in newton’s (N).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with good general health.
- •Age group: 4 to 9 years Children who can be treated using behavior management techniques.
- •Pulpotomised or pulpectomised primary molars.
- •of the root length remaining.
排除标准
- •Children with history of para functional habits, bruxism or deep bite.
- •Absence of opposing primary molars in arch.
- •Primary molars with pre-shedding mobility.
- •Presence of attrition or abrasion on the opposing primary molars.
结局指标
主要结局
1. To assess the clinical efficacy of prefabricated bioflx crowns in primary molars using
时间窗: review at baseline, 1,3 and 6 months.
marginal integrity, crown retention, gingival response, plaque accumulation & wear of opposing teeth
时间窗: review at baseline, 1,3 and 6 months.
次要结局
- 2. To evaluate parental & child acceptance.(review at baseline,1,3 & 6 months.)
- 3. To evaluate the bite force pre & post-cementation of bioflx crown(review at baseline, 1,3 & 6 months.)
研究者
Dr Harshitha V R
The Oxford dental college and hospital.