An interventional study of Prefabricated CAD/CAM PEEK with 0.2 mm thickness and Prefabricated CAD/CAM PEEK with 0.4 mm thickness in Dental Esthetic, Dental Care for Children, Dental Crowns, sponsored by Arab International University. Completed at 1 site in Syria. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Arab International University · Not applicable, Interventional, and Treatment
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.
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.
Arab International University is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.2 mm wall thickness.
Procedure: Prefabricated CAD/CAM PEEK with 0.2 mm thickness
Minimally prepared teeth restored with prefabricated PEEK crowns of 0.4 mm wall thickness.
Procedure: Prefabricated CAD/CAM PEEK with 0.4 mm thickness
Teeth receiving comprehensive preparation and restored with CAD/CAM-fabricated PEEK crowns following the NuSmile preparation protocol.
Procedure: CAD/CAM-fabricated PEEK Crowns
Minimally prepared teeth restored with prefabricated stainless steel crowns, as the positive control group.
Procedure: Satinless steel crowns
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.
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.
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.
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
Gingival Index
0 = No gingival inflammation. 1. = Mild inflammation with slight changes in color and texture affecting part of the marginal gingiva or papilla. 2. = Mild inflammation with changes in color and texture involving the entire marginal gingiva or papilla. 3. = Moderate gingival inflammation with obvious redness, surface glazing, edema, and/or enlargement of the marginal gingiva or papilla. 4. = Severe gingival inflammation with marked redness, edema and/or enlargement of the marginal gingiva or papilla, spontaneous bleeding, and ulceration.
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
Plaque Index
0 = No plaque accumulation around the gingival margin. 1. = Slight plaque accumulation detected only by passing a probe. 2. = Moderate plaque accumulation visible to the naked eye. 3. = Heavy plaque accumulation on the crown surface, gingiva, and interdental areas.
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
Bleeding on Probing
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.
Time frame: Baseline, 3 months, 6 months, and 12 months postoperatively
Wong-Baker Faces Scale
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.
Time frame: Baseline, 3 months, 6 months, 12 months postoperatively
Color Stability
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. 1. = Slight change from the original color. 2. = Unacceptable color change.
Time frame: 3 months, 6 months, 12 months postoperatively
Restoration retention and integrity
The clinical condition of the crown is evaluated during follow-up visits according to the following criteria: 0 = No visible fracture. 1. = Minor crown fracture that is repairable. 2. = Major crown fracture that can still be repaired. 3. = Crown loss and exclusion from the study sample.
Time frame: 3 months, 6 months, 12 months postoperatively
Marginal Adaptation
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.
Time frame: 3 months, 6 months, 12 months postoperatively
Patient/Parent Satisfaction
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: 1. = Completely satisfied with both esthetic and functional outcomes. 2. = Satisfied with esthetic and functional outcomes with a minor remark. 3. = Minor criticism without negative clinical effects or esthetic defects. 4. = Desire for improvement in esthetic and functional aspects. 5. = Completely dissatisfied.
Time frame: 3 months, 6 months, 12 months postoperatively
Plan to share: No
Ran from Apr 2024 to primary completion in Dec 2025, 20 months.
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Arab International University