Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Crown retention
研究概览
简要总结
The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients.
The main questions it aims to answer are:
Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins?
Researchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar.
Participants:
- Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar.
- Participants will be recalled and evaluated after 3, 6, and 12 months.
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
- None
盲法说明
Data analyst
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-9 years old.
- •American Society of Anesthesiologists Classification I or II status.
- •Cooperative child.
- •Obtained informed consent.
- •Two primary lower second molars requiring full coverage restorations.
- •Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.
- •Primary lower second molars that can be adequately isolated.
- •Pulptomized primary lower second molars.
- •Primary lower second molars with multi-surface caries.
排除标准
- •American Society of Anesthesiologists Classification higher or equal to three statuses.
- •Informed consent is not obtained.
- •Allergy to local anesthesia.
- •Non-restorable primary lower second molars.
结局指标
主要结局
Crown retention
时间窗: 3, 6, 12 months
Evaluate whether the crown is present or absent 0= present 1= absent
次要结局
- Modified gingival index(3, 6, 12 months)
- Plaque index(3, 6, 12 months)
- Occlusion(3, 6, 12 months)
- Surface roughness(3, 6, 12 months)
- Stain resistance(3, 6, 12 months)
- Wear of opposing tooth(3, 6, 12 months)
- Color match(3, 6, 12 months)
- Anatomic form(3, 6, 12 months)
- Marginal integrity and discoloration(3, 6, 12 months)
- Proximal contact(3, 6, 12 months)
- Recurrent caries(3, 6, 12 months)
研究者
Fatimah alsuwaiyan
Resident
Riyadh Elm University