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

NCT06581510 | Recruiting

• 1 other identifier: 24-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Dental Crowns

Keywords

pediatric esthetic crowns; posterior esthetic crowns

Outcome Measures

Primary Outcomes (4)

• Functional, biological , and esthetic performance according to FDI clinical criteria

  FDI World Dental Federation scores from 1-5 (highest score 1 and lowest score 5 )

  3,6,9 months

• Measure amount of reduction done after preparation

  Using superimposition technique

  During procedure

• Measure time taken during preparation

  Stopwatch / timer from start of preparation till the end of preparation

  During procedure

• Measure amount of bleeding during preparation

  Gravimetric method by weighing pre and post procedure gauze on scale

  immediately after completion of the procedure (after reduction and cementation of dental crown)

Secondary Outcomes (2)

• Patient's satisfaction while restoring primary molars

  During procedure

• Measure cost-effectiveness of each crown material

  through study completion, an average of 1 year

Study Arms (3)

Custom-Made Zirconia crowns

EXPERIMENTAL

CAD/CAM zirconia crown customized for each patient

Procedure: esthetic dental crowns

3D Printed Resin Crowns

EXPERIMENTAL

Printed resin crowns customized for each patient

Procedure: esthetic dental crowns

Ready-Made Zirconia Crowns

EXPERIMENTAL

Nuu smile ready made zirconia crown

Procedure: control group

Interventions

esthetic dental crowns PROCEDURE

Minimal Preparation of esthetic dental crown

3D Printed Resin Crowns; Custom-Made Zirconia crowns

control group PROCEDURE

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

Ready-Made Zirconia Crowns

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (2)

The British university in Egypt

Cairo, Egypt

RECRUITING

The British university in Egypt

Cairo, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 33772904 BACKGROUND

• 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.

  PMID: 35270531 BACKGROUND

• 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.

  PMID: 35808735 BACKGROUND

• 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.

  PMID: 37754145 BACKGROUND

• 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.

  PMID: 35329535 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Fatemah usama

CONTACT

+201098781655; fatemah.usama@bue.edu.eg

Sara Magdy

CONTACT

+201006786219; sara.abdelhakiem@bue.edu.eg

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: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 3, 2024
• Study Start: February 25, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)