Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates

NCT06478004 | Completed

• 1 other identifier: #841/2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Esthetic restoration of primary anterior teeth is challenging. Aim of the study: Evaluation of the 12-month clinical performance of direct resin composite restoration of carious vital primary anterior teeth using custom 3D printed templates compared to conventional strip crowns. Subjects and methods: A parallel arms randomized controlled clinical trial was performed in which 98 carious vital primary anterior teeth in 32 children were directly restored with resin composite either with the help of custom 3D printed templates (Group: A) or strip crowns (Group: B). Restorations were assessed for surface luster, anatomical form, material fracture, marginal adaptation, and periodontal response using the revised FDI criteria on three occasions; a week after placement (T0), after six months (T1), and after twelve months (T2). Comparisons between groups were evaluated. A statistically significant level was considered when p value less than or equal 0.05. The tooth was the unit of analysis.

Conditions

Primary Teeth

Keywords

Early childhood caries; Strip Crown; 3D Printing

Outcome Measures

Primary Outcomes (5)

• Surface luster

  Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

  On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

• Anatomical form

  Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

  On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

• Material fracture

  Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

  On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

• Marginal adaptation

  Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

  On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

• Periodontal response

  Assessment according to the revised clinical criteria for the evaluation of direct and indirect restorations of the World Dental Federation (FDI), Each criterion was scored according to a five-step grading of the restoration that was then dichotomized into "acceptable" (for scores 1, 2\&3) and "not acceptable" (for scores 4\&5)

  On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)

Study Arms (2)

Direct resin composite with the help of custom 3D printed templates

EXPERIMENTAL

Directly restoring carious primary anterior teeth with resin composite with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models.

Other: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates

Direct resin composite using conventional strip crowns.

ACTIVE COMPARATOR

Directly restoring carious primary anterior teeth with resin composite using conventional strip crowns.

Other: Direct composite restoration of carious primary anterior teeth using conventional strip crowns

Interventions

Direct composite restoration of carious primary anterior teeth using custom 3D printed templates OTHER

A patient dental model is acquired by digital scan then digital waxing-up is performed using the Exocad software to 3D print clear templates for direct composite resin restoration.

Direct resin composite with the help of custom 3D printed templates

Direct composite restoration of carious primary anterior teeth using conventional strip crowns OTHER

Direct composite resin restoration using celluloid crown forms

Direct resin composite using conventional strip crowns.

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presence of at least two vital carious primary maxillary incisors.
• Teeth had at least two carious surfaces requiring complete coronal restoration.

You may not qualify if:

• Children with malocclusion or parafunctional oral habits
• Teeth beyond restoration.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, Egypt

Location

Study Officials

• Mina Yassa, Doctor

  Faculty of Dentistry, Minia University, Minia, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Paediatric and Community Dentistry Department, Faculty of Dentistry, Minia University, Minia, Egypt.

Model Details: Single-center, prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 27, 2024
• Study Start: February 15, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

EG (1)