3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars

NCT ID: NCT06047925

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-08-31

Brief Summary

The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars

Detailed Description

A total of Forty permanent first mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic.

The molars will be randomly assigned equally into two treatment groups group A 3D-printed crowns & group B prefabricated SSCs, removal of caries with a high-speed handpiece then removal of the remaining carious lesion with excavator then glass ionomer restoration will be placed, preparation of SSCs crowns will be done in Group A by reduction of occlusal surface by about 1.5 mm, Proximally, tooth reduction is made through the mesial and distal contact areas, then roundation of line angles. Proper size of crown will be selected. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. In group B reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance. Reduction will be performed on the mesial, distal, buccal, and lingual surfaces of the tooth Then roundation of the line angles will be performed. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software. The crown will be printed using 3D printer using hybrid resin material. Crown will be checked for proper fit and cemented to the tooth by self-etch adhesive.

Conditions

3D Printed Crowns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A

First permanant molar will be prepared to receive 3D printed crown

Group Type: EXPERIMENTAL

3D printed crown

Intervention Type: PROCEDURE

Reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance by 1 mm. Reduction will be performed by 1 mm on the mesial, distal, buccal and lingual surfaces of the tooth. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. Temporary crown will be placed above the preparation as temporisation.The impression will be sent to the lab .The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.The crown will be printed using 3D printer using hybrid resin(micro-filled hybrid material) material.The 3d printed crown is cemented with resin cement.

group B

First permanant molar will be prepared to receive SSC

Group Type: ACTIVE_COMPARATOR

stanless steel crown

Intervention Type: PROCEDURE

The occlusal surface of the tooth should be reduced by about 1.5 mm, maintaining its occlusal contour or until the tooth is out of occlusion with adequate room to fit a crown.Proximally, tooth reduction will be made through the mesial and distal contact areas, then roundation of line angles to avoid the creation of ledges or steps.The crown selection will be done by trial and error or by measuring the mesiodistal dimension of the tooth space with dividers. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in.

Interventions

3D printed crown

Reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance by 1 mm. Reduction will be performed by 1 mm on the mesial, distal, buccal and lingual surfaces of the tooth. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. Temporary crown will be placed above the preparation as temporisation.The impression will be sent to the lab .The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.The crown will be printed using 3D printer using hybrid resin(micro-filled hybrid material) material.The 3d printed crown is cemented with resin cement.

Intervention Type: PROCEDURE

stanless steel crown

The occlusal surface of the tooth should be reduced by about 1.5 mm, maintaining its occlusal contour or until the tooth is out of occlusion with adequate room to fit a crown.Proximally, tooth reduction will be made through the mesial and distal contact areas, then roundation of line angles to avoid the creation of ledges or steps.The crown selection will be done by trial and error or by measuring the mesiodistal dimension of the tooth space with dividers. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children included in the study should conform to the following criteria:

1. Badly broken-down endodontically treated first permanent molar

2. First permanent molar with extensive multi-surface caries.

3. First permanent molar with structural developmental defects such as hypoplasia, Molar-Incisor Hypomineralization (MIH), Amelogenesis Imperfecta, and Dentinogenesis Imperfecta

Exclusion Criteria

• Children who are uncooperative needing sedation or general anesthesia.
• Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
• Molars of poor prognosis

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Dina Bassam Mohamed Ahmed

Asisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nagwa khattab, BDS,MSc,MD

Role: STUDY_DIRECTOR

Ainshams University

Locations

Faculty of dentistry Ainshams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FDASU-RECID022321

Identifier Type: -

Identifier Source: org_study_id