Prefabricated CAD/CAM PEEK Crowns For Primary Molars Restoration
Evaluation of Minimally Prepared CAD/CAM Polyetheretherketone (PEEK) Crowns Efficacy in Restoring Primary Molars
This Split-mouth randomized clinical trial aims to evaluate CAD/CAM prefabricated Polyether ether ketone crowns for primary molars restoration after pulpotomy compared to Stainless steel crowns Over follow-up periods of 3, 6, and 12 months, the sample included 60 children aged 5-9 years who had bilateral mandibular second primary molars.
Each child received a pulpotomy treatment followed by the placement of a stainless steel crown on one side and a PEEK crown on the contralateral side, distributed randomly.
Clinical parameters were subsequently evaluated during the three follow-up periods, including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
研究概览
地位
详细说明
Interest in the esthetic aspect of pediatric dental treatment has increased among both children and parents, as children's self-perception is strongly influenced by the appearance of their teeth from an early age. Most esthetic restorative options require extensive tooth preparation compared with stainless steel crowns (SSCs). However, only limited studies have investigated conservative esthetic alternatives for primary molars.
This randomized controlled clinical trial aimed to evaluate the clinical effectiveness of CAD-CAM prefabricated esthetic PEEK crowns compared with stainless steel crowns (SSCs) in restoring primary mandibular second molars after pulpotomy. Clinical performance was assessed according to restoration retention and integrity, gingival health, plaque accumulation, bleeding on probing, marginal adaptation, color stability, and child/parent satisfaction over follow-up periods of 3, 6, and 12 months.
The sample was randomly allocated using the website: randomization.com
A total crowns were randomly distributed into four groups (n=20 per group):
(A): Prefabricated CAD/CAM PEEK crowns with 0.2 mm thickness (B): Prefabricated CAD/CAM PEEK crowns with 0.4 mm thickness (C): CAD/CAM fabricated PEEK crowns prepared according to NuSmile recommendations (D): Stainless steel crowns (SSC). The study included healthy, cooperative children aged 5-9 years requiring pulpotomy treatment for mandibular second primary.
Clinical Procedure
Clinical and radiographic examinations are performed to confirm the indication for pulpotomy treatment, followed by completion of the study form. Local anesthesia and rubber dam isolation are carried out, and pulpotomy is performed according to the conventional technique described by Dean (2016). The tooth is then restored with glass ionomer cement.
After cement setting, conservative tooth preparation is performed using diamond burs with 1-2 mm occlusal reduction. For Groups I, II, and IV, proximal reduction is completed with minimal preparation. In Group III, tooth preparation follows NuSmile recommendations, including occlusal reduction, proximal opening, crown reduction, and a 1 mm subgingival finish line.
For Groups I, II, and IV, the appropriate crown size is selected, checked for marginal adaptation and proximal contacts, then cemented using Fuji I glass ionomer cement. Excess cement is removed using a dental explorer and dental floss.
For the CAD/CAM fabricated PEEK group, a silicone impression is taken and scanned digitally. Crowns are designed using Exocad software and fabricated with CAD-CAM technology. After polishing and internal surface conditioning with aluminum oxide particles, the crown is tried in, cemented with Fuji I glass ionomer cement, and excess cement is removed.
Clinical parameters are evaluated immediately after crown cementation for directly measurable baseline variables and during the three follow-up periods (after 3, 6, 12 months), including the gingival index, plaque index, bleeding on probing index, restoration retention and integrity, marginal adaptation, color stability, and both parental and child satisfaction.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Damascus、叙利亚
- School of Dental Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Healthy children aged 5-9 years.
- Children requiring pulpotomy of mandibular second primary molars.
- Cooperative children rated as positive or definitely positive on the Frankl behavior scale.
- No acute or chronic abscess at the anesthesia site.
Exclusion Criteria:
- Root resorption exceeding the apical third.
- Non-restorable teeth.
- Presence of swelling, fistula, or acute or chronic pulpitis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Prefabricated PEEK crowns of 0.2 mm thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness.
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The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.2mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
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实验性的：Prefabricated PEEK crowns of 0.4 mm wall thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness.
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The pulpotomized molar assigned to experimental group will be received A Polyether ether ketone prefabricated crown with 0.4mm thickness on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
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实验性的：CAD/CAM-fabricated PEEK crowns
Teeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol.
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The pulpotomized molar assigned to experimental group will be received A CAD/CAM fabricated Polyether ether ketone crown on one side of mandibular arch, and the other side will be received a Stainless steel crown as control group.
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有源比较器：Stainless steel crowns
Minimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group.
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The pulpotomized molar assigned to control group will be received a Stainless steel crown as control group on one side of mandibular arch, and the other side will be received one of the arm 1, 2, or 3
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Gingival Index
大体时间：Baseline, 3 months, 6 months, and 12 months postoperatively
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0 = No gingival inflammation.
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Baseline, 3 months, 6 months, and 12 months postoperatively
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Plaque Index
大体时间：Baseline, 3 months, 6 months, and 12 months postoperatively
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0 = No plaque accumulation around the gingival margin.
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Baseline, 3 months, 6 months, and 12 months postoperatively
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Bleeding on Probing
大体时间：Baseline, 3 months, 6 months, and 12 months postoperatively
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Bleeding on probing is assessed using a Williams periodontal probe inserted into the gingival sulcus around each crowned tooth. Four sites (mesial, distal, buccal, and lingual) are examined, and bleeding is evaluated 10 seconds after probing as follows: (-) No bleeding. (+) Bleeding present. |
Baseline, 3 months, 6 months, and 12 months postoperatively
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Wong-Baker Faces Scale
大体时间：Baseline, 3 months, 6 months, 12 months postoperatively
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A Wong-Baker Faces Scale consisting of six expressive faces is used, ranging from "no hurts" to "hurts worst," to facilitate the child's selection of the appropriate face. The scale ranges from 0 to 10. The child is given a questionnaire displaying the faces immediately after crown placement and is asked to choose the face that best represents their feeling at that moment. The child indicates the selected face by pointing to it, and the response is recorded in the study form. |
Baseline, 3 months, 6 months, 12 months postoperatively
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Color Stability
大体时间：3 months, 6 months, 12 months postoperatively
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Color stability is assessed using a shade guide as a reference standard. The crown color is compared with the shade guide at each follow-up visit (3, 6, and 12 months) according to the following criteria: 0 = No color change.
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3 months, 6 months, 12 months postoperatively
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Restoration retention and integrity
大体时间：3 months, 6 months, 12 months postoperatively
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The clinical condition of the crown is evaluated during follow-up visits according to the following criteria: 0 = No visible fracture.
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3 months, 6 months, 12 months postoperatively
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Marginal Adaptation
大体时间：3 months, 6 months, 12 months postoperatively
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Marginal adaptation discrepancies were evaluated clinically using a sharp explorer and direct visual examination under dental operating light According to the modified United States Public Health Service (USPHS) criteria; (A): An Alpha grade represented a clinically ideal restoration with excellent marginal adaptation, no detectable gap on exploratory examination. (B): A Bravo grade indicated a clinically acceptable restoration with a slight marginal discrepancy detectable by an explorer, but without dentin exposure. (C): A Charlie grade was assigned to restorations that were clinically unacceptable due to a definite marginal gap, with exposed dentin. (D): A Delta grade denotes the worst clinical condition, characterized by gross marginal failure, loss of retention, or other major defects, for which complete replacement of the restoration is required. |
3 months, 6 months, 12 months postoperatively
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Patient/Parent Satisfaction
大体时间：3 months, 6 months, 12 months postoperatively
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The child and one parent are asked about their satisfaction with the crowns regarding esthetics and function, and the responses are recorded in the patient form. Evaluation is performed as follows:
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3 months, 6 months, 12 months postoperatively
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合作者和调查者
调查人员
- 首席研究员：Bushra Munzer Shamma, MSc, DDS.、Damascus University
- 学习椅：Mohannad Laflouf, PhD, MSc, DDS.、Damascus University
- 研究主任：Saleh Al Kurdi, PhD, MSc, DDS.、Arab International University
出版物和有用的链接
一般刊物
- Attia MA, Blunt L, Bills P, Tawfik A, Radawn M. Micro-CT analysis of marginal and internal fit of milled and pressed polyetheretherketone single crowns. J Prosthet Dent. 2023 Jun;129(6):906.e1-906.e10. doi: 10.1016/j.prosdent.2023.03.018. Epub 2023 Apr 16.
- Heimer S, Schmidlin PR, Roos M, Stawarczyk B. Surface properties of polyetheretherketone after different laboratory and chairside polishing protocols. J Prosthet Dent. 2017 Mar;117(3):419-425. doi: 10.1016/j.prosdent.2016.06.016. Epub 2016 Sep 28.
- Chen Y, Liu W, Wu Z, Wang S, Li Y, Su B, Li S. Advantages and feasibility of prefabricated PEEK crowns for aesthetic restoration in primary teeth. Sci Rep. 2024 Nov 18;14(1):28398. doi: 10.1038/s41598-024-79306-1.
- Stawarczyk B, Beuer F, Wimmer T, Jahn D, Sener B, Roos M, Schmidlin PR. Polyetheretherketone-a suitable material for fixed dental prostheses? J Biomed Mater Res B Appl Biomater. 2013 Oct;101(7):1209-16. doi: 10.1002/jbm.b.32932. Epub 2013 Apr 6.
- Skirbutis G, Dzingute A, Masiliunaite V, Sulcaite G, Zilinskas J. PEEK polymer's properties and its use in prosthodontics. A review. Stomatologija. 2018;20(2):54-58.
- Nagarathna, C., Deepthi, L., & Cam, C. A. D. (2026). Next Generation Smile Solutions - PEEK Crowns in Pediatric Dentistry. Journal of Chemical Health Risks, 16(1), 1734-1742.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 106/SRC/Sep.23.2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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