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Completed

NCT Number: NCT06478004

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

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.

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Key information

Conditions

Primary Teeth

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Minia University

Minya, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 composite restoration of carious primary anterior teeth using conventional strip crowns

Other

Direct composite resin restoration using celluloid crown forms

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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