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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-04-15

Brief Summary

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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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Detailed Description

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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).

Conditions

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Primary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, prospective randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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 using conventional strip crowns.

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Direct composite resin restoration using celluloid crown forms

Interventions

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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.

Intervention Type OTHER

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

Direct composite resin restoration using celluloid crown forms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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