Evaluation of Clinical Performance, Parent's Satisfaction, Gingival Health and Bacterial Effects of Bioflex Crowns & Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- retention of bio-flex crown,zirconia, and endo-crown
研究概览
简要总结
This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns &Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars
详细描述
Intervention: Pulptomy Procedures The tooth will be anaesthetized. Then, it will be isolated using a rubber dam. Caries will be removed with a sterile non-end cutting bur # 558 to complete the removal of the pulp chamber roof under copious water coolant spray. Coronal pulp tissue remnants will be removed with a sharp, sterile excavator. A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes. After removing the formocresol pellet, a thick mix of zinc- oxide/eugenol paste will be packed into the pulp chamber to seal the orifices.
Restoration of the tooth:
According to the groups restoration will be as the following:
Group A: Endocrowns tooth preparation, scanning, cementation:
For the endocrowns A layer of light -cured glass ionomer cement ° of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 - Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length.
排除标准
- •Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health.
- •Presence of para-functional habits. Such bruxism, TMJ disorders
- •Non-restorable tooth.
- •Teeth with non-vital pulp
研究组 & 干预措施
bio-flex crown
bio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
干预措施: treatment option for primary second molar (Procedure)
endo-crown
endo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
干预措施: treatment option for primary second molar (Procedure)
zirconia crown
zirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
干预措施: treatment option for primary second molar (Procedure)
结局指标
主要结局
retention of bio-flex crown,zirconia, and endo-crown
时间窗: follow up will be 3,6,9,12 month
Retention were scored using a modified United States Public Health Service (USPHS) criterion.
marginal adaptation of bio-flex crown,zirconia, and endo-crown
时间窗: follow up will be 3,6,9,12 month
marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion.
gingival health of bio-flex crown,zirconia, and endo-crown
时间窗: follow up will be 3,6,9,12 month
• Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
fracture of restoration of bio-flex crown,zirconia, and endo-crown
时间窗: follow up will be 3,6,9,12 month
fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion.
次要结局
- parent's satisfaction analysis(follow up will be 3,6,9,12 month)
研究者
kareem ragab abdallah el hosary
head of dental depertment -tanta militery hospital
Al-Azhar University