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

NCT ID: NCT06583759

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2026-01-15

Brief Summary

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.

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stainless Steel Crowns

Group Type: ACTIVE_COMPARATOR

Full coverage Crowns

Intervention Type: PROCEDURE

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

PEEK Crowns

Group Type: EXPERIMENTAL

Full coverage Crowns

Intervention Type: PROCEDURE

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

Interventions

Full coverage Crowns

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Rodaina Helmy

Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aly Sharaf, Professor, Pediatric Dentistry

Role: STUDY_DIRECTOR

Alexandria University

Locations

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

AlexU

Identifier Type: -

Identifier Source: org_study_id