Custom-Made Zirconia Crowns and 3D-Printed Resin Crowns Versus Ready-Made Zirconia Crowns in Primary Molars

NCT ID: NCT06581510

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2026-02-23

Brief Summary

The main problem introduced in this study is the aggressive reduction needed for ready-made zirconia crowns to be passively fitted. In addition, its relatively expensive cost and wear of the opposing tooth structure. In this study, different crown materials will be introduced, such as customized zirconia crowns and novel 3D printed resin crowns who may offer better adaptability and gingival health and are relatively cost effective. The proposed study will help in increasing studies of different crown materials for primary teeth

Detailed Description

According to AAPD, pulpally treated or deep carious primary teeth should be restored with full coverage crowns for protection of the remaining tooth structure and integrity of occlusion. Different crown materials and compositions have been introduced; however, each with their own drawbacks. Stainless steel crowns have remained the gold standard for restoring primary molars, with the advantages of minimal preparation needed and better adaptability of margins due to their burnishing ability. On the other hand, stainless steel crowns suffer from poor aesthetics and gingival health. The aesthetics of pre-veneered stainless-steel crowns improved but were significantly reduced when the veneered surface was chipped, which was a major drawback in the crown; in addition to their decreased strength and durability in comparison to stainless steel crowns. Strip crowns and polycarbonate crowns were also introduced; however, because of their weak bonding capacity, they have poor strength and an uncertain position in the posterior primary teeth. Due to the increase of aesthetic demand in pediatric dentistry, zirconia crowns have been introduced. Zirconia crowns present the highest aesthetics compared to different pediatric crowns and highest strength compared to all ceramic restorations. However, they need very deep subgingival preparation, poor adaptability because it can't be crimped due to poor burnishing ability and relatively expensive.

Recently, new advances in pediatric crowns have been introduced including computerized 3D printed resin or milled zirconia crowns. Those recent advances have promising results in aesthetics and strength in comparison to ready-made zirconia crowns. Ready-made zirconia crowns have been an exceptionally good biocompatible material. One of the main benefits of those crowns is their durability alongside an outstanding aesthetic appearance. Furthermore, because of their extremely polished surface, ready-made zirconia crowns have proved to have less plaque buildup when compared to other materials. However, because they are costly, need extensive sub-gingival tooth reduction, and cause wear of opposing tooth structure, there are several clinical restrictions and drawbacks.

New computer-aided design digital models serve as the foundation for three-dimensional (3D) printing technologies, which are sophisticated manufacturing techniques that generate customized 3D objects automatically. With applications in almost all fields of dentistry, three-dimensional printing fabricates excellent fitted, accurate, and biocompatible crowns that may overcome ready-made zirconia crowns.

On the other hand, currently the zirconia-based CAD/CAM system has the strongest fracture strength of any all-ceramic material and has continuously produced the most accurate, aesthetically pleasing replication of natural dentition.

They've been acknowledged by patients and dentists alike. The zirconia-based CAD/CAM system is recommended for crowns and bridges in natural teeth, implants, and telescopic dentures. Customized zirconia crowns could be an alternative to the drawbacks presented in ready-made zirconia crowns

Conditions

Dental Crowns

Study Design

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

Study Groups

Custom-Made Zirconia crowns

CAD/CAM zirconia crown customized for each patient

Group Type: EXPERIMENTAL

esthetic dental crowns

Intervention Type: PROCEDURE

Minimal Preparation of esthetic dental crown

3D Printed Resin Crowns

Printed resin crowns customized for each patient

Group Type: EXPERIMENTAL

esthetic dental crowns

Intervention Type: PROCEDURE

Minimal Preparation of esthetic dental crown

Ready-Made Zirconia Crowns

Nuu smile ready made zirconia crown

Group Type: EXPERIMENTAL

control group

Intervention Type: PROCEDURE

Nuu smile ready-made zirconia crown with its well-known reduction

Interventions

esthetic dental crowns

Minimal Preparation of esthetic dental crown

Intervention Type: PROCEDURE

control group

Nuu smile ready-made zirconia crown with its well-known reduction

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy children within age range of 5-8 years old
• Upper and lower primary second molars
• Vital primary second molars
• Cooperative children Frankl scale 3 (positive) and 4 (definitely positive)

Exclusion Criteria

• Radiographic radiolucency related to the furcation and periapical area or any evidence of root resorption
• Deep bite
• More than 2 walls lost due to caries
• Presence of parafunctional habits

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Fatema usama

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The British university in Egypt

Cairo, , Egypt

Site Status: RECRUITING

The British university in Egypt

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Fatemah usama

Role: CONTACT

fatemah.usama@bue.edu.eg

+201098781655

Sara Magdy

Role: CONTACT

sara.abdelhakiem@bue.edu.eg

+201006786219

Facility Contacts

Fatemah usama

Role: primary

fatemah.usama@bue.edu.eg

01098781655

Sara Magdy

Role: backup

sara.abdelhakiem@bue.edu.eg

01006786219

Noha Kabil, Professor

Role: primary

noha.kabil@bue.edu.eg

+201005131500

References

Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.

Reference Type: BACKGROUND

PMID: 33772904 (View on PubMed)

Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.

Reference Type: BACKGROUND

PMID: 35270531 (View on PubMed)

Jain S, Sayed ME, Shetty M, Alqahtani SM, Al Wadei MHD, Gupta SG, Othman AAA, Alshehri AH, Alqarni H, Mobarki AH, Motlaq K, Bakmani HF, Zain AA, Hakami AJ, Sheayria MF. Physical and Mechanical Properties of 3D-Printed Provisional Crowns and Fixed Dental Prosthesis Resins Compared to CAD/CAM Milled and Conventional Provisional Resins: A Systematic Review and Meta-Analysis. Polymers (Basel). 2022 Jun 30;14(13):2691. doi: 10.3390/polym14132691.

Reference Type: BACKGROUND

PMID: 35808735 (View on PubMed)

Dewan H. Clinical Effectiveness of 3D-Milled and 3D-Printed Zirconia Prosthesis-A Systematic Review and Meta-Analysis. Biomimetics (Basel). 2023 Aug 27;8(5):394. doi: 10.3390/biomimetics8050394.

Reference Type: BACKGROUND

PMID: 37754145 (View on PubMed)

Sztyler K, Wiglusz RJ, Dobrzynski M. Review on Preformed Crowns in Pediatric Dentistry-The Composition and Application. Materials (Basel). 2022 Mar 11;15(6):2081. doi: 10.3390/ma15062081.

Reference Type: BACKGROUND

PMID: 35329535 (View on PubMed)

Other Identifiers

24-010

Identifier Type: -

Identifier Source: org_study_id