Effectiveness of Bioceramic Calcium Silicate-based Pulpotomy Medicament on Primary Molars Restored With 3d Printed Resin Crowns (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical success of pulpotomy at 1 week
研究概览
简要总结
children aged 5 to 7 years with deep carious second primary molars that require vital pulp therapy will be treated using either MTA or bioceramic putty, then will be fully covered using either stainless steel crowns or 3D printed resin crowns.
详细描述
removal of caries from second primary molars reaching the pulp, pulpotomy will be done by controlling the bleeding after that pulp chamber will be covered with either MTA or endosequence bioceramic putty.
resin modified glass ionomer will be placed, crown preparation will be done to receive full coverage either stainless steel crowns or 3D printed resin crowns
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
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged from 5 to 7 years.
- •Medically healthy children (ASA I) (Appendix I)
- •Positive or definitely positive behavior (Frankl's rating scale scores III or IV) (Appendix II)
- •Parents/legal guardians who provide written informed consent Tooth inclusion criteria(8, 14, 31)
- •Deep carious second primary molars with:
- •Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.
- •Signs of reversible pulpitis. 10
- •Require full coverage restorations
- •Cooperative children (Frankl 3 or 4 behavior rating scale)
排除标准
- •History of spontaneous pain.
- •Tooth mobility.
- •Excessive bleeding from radicular stumps after coronal pulp amputation.
- •Radiographic evidence of pathological root resorption, inter-radicular bone loss, periapical pathology, or canal calcifications.
- •Previous dental treatment of the involved molar.
- •Children with special healthcare needs.
结局指标
主要结局
clinical success of pulpotomy at 1 week
时间窗: clinical success at 1 week
Clinical success: Absence of pain, sensitivity to percussion, swelling, or fistula.
clinical success of pulpotomy at 6 months
时间窗: clinical success at 6 months
Absence of pain, sensitivity to percussion, swelling, or fistula.
clinical success of pulpotomy at 12 months
时间窗: clinical success at 12 months
Absence of pain, sensitivity to percussion, swelling, or fistula.
radiographic success of pulpotomy at 1 week
时间窗: radiographic success at 1 week
No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
radiographic success of pulpotomy at 6 months
时间窗: radiographic success at 6 months
No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
radiographic success of pulpotomy at 12 months
时间窗: radiographic success at 12 months
No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
Crown evaluation at 6 months using Modified United States Public Health Service
时间窗: at 6 months
Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion. Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear. Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C
crown evaluation at 12 months using Modified United States Public Health Service
时间窗: at 12 months
Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion. Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear. Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C
次要结局
- Parental satisfaction Assessed immediately after treatment using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction(immediately after treatment)
- Parental satisfaction Assessed after 1 week using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction(parental satisfaction after 1 week)
- parental satisfaction assessed after 6 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction(parental satisfaction after 6 months)
- parental satisfaction assessed after 12 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction(parental satisfaction after 12 months)
- Child satisfaction Measured immediately post-cementation using a Smiley Face Likert scale in child-friendly language.(immediately after crown cementation)
研究者
Yousr Nader
pediatric dentistry specialist
Alexandria University