Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars

Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars: A Randomised Controlled Clinical Trial

Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: Full coverage Crowns

Detailed Description

A two-arm randomized controlled clinical trial. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar indicated for full coverage. Written informed consent will be obtained from their guardians. Participants will be randomly allocated into two groups according to the crown that will be used. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. Using Modified Ryge's Criteria, the crowns will be examined clinically for anatomic form, restoration staining, marginal discoloration, colour match, surface roughness, marginal adaptation, proximal contact, occlusal wear of crown, wear of opposing tooth, and presence of cracks. Gingival and Plaques index scores will be recorded, as well as chairside time, patient and parental satisfaction. The patients will be recalled at 1 week then 3, 6 and 12 months for clinical follow-up. Radiographs will be taken at 6 and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University
  • Alexandria, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant Inclusion Criteria

   • Age ranges from 5 - 7 years.
   • Children free of any systemic disease or special health care need (ASA I).(30)
   • Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4) (Appendix I).(31)
   • Patients whose parents will give their consent to participate.

2. Tooth Inclusion Criteria

   • Mandibular second primary molars that are indicated for full coverage:(7)
   • Present opposing tooth.

Tooth Exclusion Criteria:

• Root resorption affecting more than one third of the root length.
• Clinical signs and symptoms of irreversible pulpitis or non-vitality. (Appendix II) (32)
• Fistula or abscess related to the selected tooth clinically and radiographically.
• Non restorable crowns.
• Signs of mobility or bone resorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stainless Steel Crowns	Procedure: Full coverage Crowns; The crown will be prepared accordingly. Try in of the best fitted crown will be done and cementation.
Experimental: PEEK Crowns	Procedure: Full coverage Crowns; The crown will be prepared accordingly. Try in of the best fitted crown will be done and cementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical Evaluation of the crown using Modified Ryge Criteria	Day 0, 1 week , 3 months, 6 months , 12 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Aly Sharaf, Professor, Pediatric Dentistry, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: AlexU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No