Digital Crowns Versus Prefabricated Crowns on Primary Teeth

Crowns Fabricated Digitally by CAD-CAM Technology Versus Prefabricated Crowns on Primary Teeth

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: Digital crowns; Procedure: zirconia crowns

Detailed Description

This is a 12-month randomized, controlled, two parallel arms clinical trial. Patients aging from 4 to 10 years with multi-surface decay will be selected. After caries removal and pulp exposure, pulpotomy or partial pulpectomy technique will be performed,then the teeth will be randomized to the interventional group of digital crowns or to the control group of prefabricated zirconia crowns. For preparation of digital crowns, the occlusal reduction was done by 1.5-2 mm. The proximal contacts will be broken and the entire clinical crown structure was reduced by 0.8-1.0 mm , followed by a a subgingival finish line . For the scanning procedure, the upper and lower arches will be scanned with intra oral scanner, and making sure every point is well detailed . A third scan of the occlusal bite is then performed in order to establish the patient's occlusion.

For the milling procedure, Brilliant Crios composite the blocks will be used and milled with the CEREC MC X milling unit . The inner surface of the crown will be sandblasted with Al2O3 .

For zirconia crown preparation, occlusal reduction of 1.5-2mm will be performed by a football diamond bur. The occlusal third of the buccal and lingual surfaces will be also reduced . 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 feather-edge.

The crowns will then be cemented with the self-adhesive resin cement (Solocem, Coltene, Whaledent, Altstatten, Switzerland) .Light curing was performed while applying pressure on the crown and then waiting for 5 minutes for complete cementing

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital crowns; 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; crowns fabricated digitally by CAD-CAM technology; Other Names: CAD-CAM fabricated crowns
Active Comparator: Zirconia crowns; 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; crowns that are ready made for primary teeth; Other Names: prefabricated crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of the crowns	It will be recorded by clinical examination as a binary outcome; Yes: if crown is retentive & No: if crown is unretentive	1, 6 and 12 months
Gingival inflammation	It was measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each crowned tooth. Scoring as follows: 0 = Normal (Absence of inflammation); = Mild gingivitis (slight change in color, slight edema. No bleeding on probing); = Moderate gingivitis (redness, edema and glazing. Bleeding on probing); = Severe gingivitis (marked redness and edema; ulceration;tendency to spontaneous bleeding	1, 6 and 12 months
Color match	The color match will be recorded in natural light with the patient in the upright position for 5 to 10 seconds. No noticeable difference from adjacent teeth, Slight shade mismatch , Obvious shade mismatch and will be recorded digitally by vita easy shade	1, 6 and 12 months
Opposing tooth wear	The wear of opposing teeth for the crowns placed will be measured by Smith and Knight Index and it will be measured digitally by a software	1, 6 and 12 month

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Investigators: Study Director: Hend Hafez, Professor, National Research Centre, Egypt

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: primary teeth; zirconia crowns; digital crowns
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 152012023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All required data will be published in the manuscript or upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No