Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305845
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-03-05
Brief Title:
Digital Crowns Versus Prefabricated Crowns on Primary Teeth
Sponsor:
National Research Centre Egypt
Organization:
National Research Centre Egypt
Study Overview
Official Title:
Crowns Fabricated Digitally by CAD-CAM Technology Versus Prefabricated Crowns on Primary Teeth
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 performedthen 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 15-2 mm The proximal contacts will be broken and the entire clinical crown structure was reduced by 08-10 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 patients 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 15-2mm 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 08-10 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
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 15-2mm 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 08-10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None