Digital Crowns Versus Prefabricated Crowns on Primary Teeth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized clinical trial with two parallel arms

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

participants will not be informed of which crown they will receive

Study Groups

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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.

Group Type EXPERIMENTAL

Digital crowns

Intervention Type PROCEDURE

crowns fabricated digitally by CAD-CAM technology

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.

Group Type ACTIVE_COMPARATOR

zirconia crowns

Intervention Type PROCEDURE

crowns that are ready made for primary teeth

Interventions

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Digital crowns

crowns fabricated digitally by CAD-CAM technology

Intervention Type PROCEDURE

zirconia crowns

crowns that are ready made for primary teeth

Intervention Type PROCEDURE

Other Intervention Names

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CAD-CAM fabricated crowns prefabricated crowns

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No