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Completed

NCT Number: NCT06583759

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

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Treatment and study plan

Full coverage Crowns

Procedure

The crown will be prepared accordingly. Try in of the best fitted crown will be done and cementation.

Primary outcomes

  1. Clinical Evaluation of the crown using Modified Ryge Criteria

    Time frame: Day 0, 1 week , 3 months, 6 months , 12 months

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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