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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06047925
Collaborator
(none)
40
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2
24
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: 3D printed crown
  • Procedure: stanless steel crown
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one experimental group and one active comparator groupone experimental group and one active comparator group
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
Double (Investigator-outcome Assessor)
Primary Purpose:
Treatment
Official Title:
3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars (Randomized Controlled Clinical Trial)
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: group A

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

Procedure: 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 composite) material.The 3d printed crown is cemented with resin cement.

Active Comparator: group B

First permanant molar will be prepared to receive SSC

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.

Outcome Measures

Primary Outcome Measures

  1. The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars [3,6,12 and 18 months]

    Evaluation of clinical performance of both crowns regarding gingival health (gingival & plaque index) and Fracture, retention, marginal discoloration and surface texture according to the modified United states Public Health Service (USPHS) criteria. 3,6-12 and 18 months.

Secondary Outcome Measures

  1. Patient and parent satisfaction. [3,6,12 &18 months]

    Parental satisfaction will be assessed at to determine their satisfaction level with 5-point Likert scale where 1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied. Child's perception regarding their esthetics with crowns will be also considered in this study. Children will be asked to rank the crowns based on "Smiley Face Likert Scale."

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry Ainshams university Cairo Egypt 11361

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Study Director: Nagwa khattab, BDS,MSc,MD, Ainshams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dina Bassam Mohamed Ahmed, Asisstant lecturer, Ain Shams University
ClinicalTrials.gov Identifier:
NCT06047925
Other Study ID Numbers:
  • FDASU-RECID022321
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dina Bassam Mohamed Ahmed, Asisstant lecturer, Ain Shams University

Study Results

No Results Posted as of Sep 21, 2023