NCT06583759

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

October 2, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

September 2, 2024

Last Update Submit

October 1, 2025

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Clinical Evaluation of the crown using Modified Ryge Criteria

    Day 0, 1 week , 3 months, 6 months , 12 months

Study Arms (2)

Stainless Steel Crowns

ACTIVE COMPARATOR
Procedure: Full coverage Crowns

PEEK Crowns

EXPERIMENTAL
Procedure: Full coverage Crowns

Interventions

Full coverage CrownsPROCEDURE

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

PEEK CrownsStainless Steel Crowns

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Aly Sharaf, Professor, Pediatric Dentistry

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer, Pediatric dentistry department, Faculty of dentistry

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 4, 2024

Study Start

November 14, 2024

Primary Completion

December 15, 2025

Study Completion

January 15, 2026

Last Updated

October 2, 2025

Record last verified: 2025-10

Locations

EG(2)