NCT06690229

Evaluation of Different Cementation Materials Used in Prefabricated Pediatric Zirconia Crowns

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Not accepted

Summary

Today, with increasing aesthetic demands; the need for materials that are both durable and compatible with the appearance of natural teeth is increasing in paediatric dentistry. Prefabricated zirconium crowns have attracted significant interest in recent years because they meet aesthetic expectations and have offer mechanical strength. There are various traditional and contemporary cement options that can be used for cementation of crowns. The aim of this study is to clinically evaluate prefabricated zirconia crowns cemented to the primary maxillary incisors with three different adhesive cements in terms of periodantal health, plaque accumulation, opposing tooth wear, parental satisfaction, color harmony, retention, marginal integrity and contact compatibility, at the 1-week, 3-month, 6-month, 12-month follow-ups.

Detailed description

The sample size was calculated as 30 with the G\*Power analysis program. Considering the case losses, the sample size will be increased by 20% and a total of 36 teeth will be included. In the study, 3 different cements will be applied to each cement group, 12 teeth. In this study, 36 teeth will be included from patients aged 3-4 years who have two or more surface carious lesions on their maxillary incisors. After necessary caries removal and pulpectomy treatment, prefabricated zirconia crowns will be prepared and cemented under general anesthesia, using one of three randomly selected cements. 12 teeth will be cemented with FujiCEM Evolve (GC, Tokyo, Japan) 12 teeth with RelyX U200 (3M ESPE, St. Paul, USA) 12 teeth with Ketac Cem (3M ESPE, USA) Patients will be called for follow-up examinations one week after the completion of all dental treatments and at 3, 6, and 12 months. During these follow-ups, Gingival Index, Plaque Index, Tooth Wear Index, and Ryge (USPHS) Criteria will be evaluated on the teeth, and a parental satisfaction scale will be completed.

Conditions

• Caries,Dental

Interventions

Type	Name	Description
DRUG	glass ionomer cement	A cement used for crown cementation
DRUG	self-adhesive resin cement	A cement used for crown cementation
DRUG	resin modified glass ionomer cement	A cement used for crown cementation

Timeline

• Start date: 2024-06-05
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2024-11-15
• Last updated: 2025-11-21

Locations

1 site across 1 country: Turkey (Türkiye)