Digital Crowns Versus Prefabricated Crowns on Primary Teeth

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06305845
• Other study ID #: 152012023
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: September 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Procedure:
• Digital crowns
crowns fabricated digitally by CAD-CAM technology
• zirconia crowns
crowns that are ready made for primary teeth

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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