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

June 27, 2024 updated by: Mina Kamal Yassa, Minia University

Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is a single-center randomized controlled clinical trial with 1:1 allocation ratio. This trial entailed directly restoring carious primary anterior teeth with resin composite either with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models (Group: A) or conventional strip crowns (Group: B). Restorations were assessed for clinical performance on three occasions; postoperatively (T0), after six months (T1), and after twelve months (T2).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt
        • Faculty of dentistry, Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct resin composite with the help of custom 3D printed templates
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
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.
Active Comparator: Direct resin composite using conventional strip crowns.
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
Direct composite resin restoration using celluloid crown forms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface luster
Time Frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
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
Time Frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
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
Time Frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
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
Time Frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
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
Time Frame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Mina Yassa, Doctor, Faculty of Dentistry, Minia University, Minia, Egypt.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

June 15, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • #841/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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