Using CAD/CAM PEEK crowns for treating dental caries in children's molars
Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars: A Randomised Controlled Clinical Trial
This study is testing whether CAD/CAM PEEK crowns work better than stainless steel crowns for treating cavities in the back teeth of healthy children aged 5 to 7.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 5 Years to 7 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria and 1 other locations) |
| Trial ID | NCT06583759 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 50 healthy children aged 5-7 years who will be randomly assigned to receive either CAD/CAM PEEK crowns or stainless steel crowns (SSC) for their mandibular second primary molars. The study aims to evaluate the clinical and radiographic outcomes of these two types of crowns over a 12-month period. Participants will be monitored for various factors including crown integrity, patient satisfaction, and oral health indices. The trial will follow a structured schedule of clinical evaluations and radiographic assessments at specified intervals.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 5-7 years with specific dental needs for full coverage of their mandibular second primary molars.
Not a fit: Patients with systemic diseases, severe dental issues, or those requiring non-restorable crowns will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and aesthetically pleasing option for dental restoration in children.
How similar studies have performed: While the use of CAD/CAM technology in dentistry is growing, this specific application in pediatric dentistry is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Alexandria and 1 other locations
- Faculty of Dentistry, Alexandria University — Alexandria, Egypt (Recruiting)
- Faculty of Dentistry — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Rodaina H Helmy
- Email: rodainahhelmy@gmail.com
- Phone: +201100001193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.