Digital Crowns Versus Prefabricated Crowns on Primary Teeth

NCT06305845 | Active Not Recruiting

• 1 other identifier: 152012023
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. For the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. Teeth will be followed up clinically for 1 year, at 1, 6 and 12 months.

Conditions

Dental Caries in Children

Keywords

digital crowns; zirconia crowns; primary teeth

Outcome Measures

Primary Outcomes (1)

• Patient and parent satisfaction

  5-point Likert scale for patient and parent satisfaction.(1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)

  1, 6 and 12 months

Secondary Outcomes (4)

• Retention of the crowns

  1, 6 and 12 months

• Gingival inflammation

  1, 6 and 12 months

• Color match

  1, 6 and 12 months

• Opposing tooth wear

  1, 6 and 12 month

Study Arms (2)

Digital crowns

EXPERIMENTAL

Crowns that are fabricated digitally by mean of CAD-CAM technology will be placed after preparation. Tooth preparation will include 1.5-2 mm. occlusal reduction and proximal contacts will be opened and the entire clinical crown structure will be reduced by 0.8-1.0 mm.and the preparation will be finished with a subgingival finish line. Upper and lower arches will be scanned with an intra oral scanner. A third scan of the occlusal bite is then performed in order to establish the patient's occlusion. Brilliant Crios composite blocks will be milled with the CEREC MC X milling unit and the inner surface of the crown will be sandblasted followed by etching with 5% hydrofluoric acid for 60 seconds.

Procedure: Digital crowns

Zirconia crowns

ACTIVE COMPARATOR

Prefabricated zirconia crowns that are ready made and supplied in kits with their try-ins will be used in this arm. Occlusal reduction of 1.5-2 mm. will be performed by a football diamond bur. The whole crown will be reduced by 0.8-1.0 mm by means of a tapered diamond stone. A shoulder finish line will be created. The try in crown will be tested. Then the shoulder finish line will be removed and the preparation will be extended subgingivally to a feather-edge.

Procedure: zirconia crowns

Interventions

Digital crowns PROCEDURE

crowns fabricated digitally by CAD-CAM technology

Also known as: CAD-CAM fabricated crowns

Digital crowns

zirconia crowns PROCEDURE

crowns that are ready made for primary teeth

Also known as: prefabricated crowns

Zirconia crowns

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients within the age group of 4-10years. Badly decayed or multi-surface affected primary teeth Healthy children free of any systemic disease Patients with cooperative behavior rating definitely positive or positive on the Frank rating scale

You may not qualify if:

• Teeth with developmental disturbances
• Teeth with poor prognosis as signs of necrosis, extensive pathological root resorption
• patients with parafunctional habits

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Egypt

Location

Related Publications (4)

• Prabhu D, Anantharaj A, Praveen P, Rani SP, Sudhir R. A clinical and radiographic comparative evaluation of custom-made zirconia crowns using CAD-CAM and stainless steel crowns in primary molars. J Indian Soc Pedod Prev Dent. 2022 Jan-Mar;40(1):34-42. doi: 10.4103/jisppd.jisppd_269_21.

  PMID: 35439881 BACKGROUND

• Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.

  PMID: 27306242 BACKGROUND

• Mourouzis P, Arhakis A, Tolidis K. Computer-aided Design and Manufacturing Crown on Primary Molars: An Innovative Case Report. Int J Clin Pediatr Dent. 2019 Jan-Feb;12(1):76-79. doi: 10.5005/jp-journals-10005-1591.

  PMID: 31496579 BACKGROUND

• Al-Halabi MN, Bshara N, Nassar JA, Comisi JC, Rizk CK. Clinical Performance of Two Types of Primary Molar Indirect Crowns Fabricated by 3D Printer and CAD/CAM for Rehabilitation of Large Carious Primary Molars. Eur J Dent. 2021 Jul;15(3):463-468. doi: 10.1055/s-0040-1721905. Epub 2021 Feb 3.

  PMID: 33535245 BACKGROUND

Study Officials

• Hend Hafez, Professor

  National Research Centre, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will not be informed of which crown they will receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized clinical trial with two parallel arms

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: June 1, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 1, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)