Clinical trial NCT06305845: Digital Crowns Versus Prefabricated Crowns on Primary Teeth
Official title: Crowns Fabricated Digitally by CAD-CAM Technology Versus Prefabricated Crowns on Primary Teeth
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Keywords: digital crowns
zirconia crowns
primary teeth
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 58
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized clinical trial with two parallel arms
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Patient and parent satisfaction
timeFrame: 1, 6 and 12 months
Secondary outcomes:
measure: Retention of the crowns
timeFrame: 1, 6 and 12 months
measure: Gingival inflammation
timeFrame: 1, 6 and 12 months
measure: Color match
timeFrame: 1, 6 and 12 months
measure: Opposing tooth wear
timeFrame: 1, 6 and 12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
affiliation: National Research Centre, Egypt
name: Hend Hafez, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.