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

Minia University

Status: Completed

Conditions: Primary Teeth

Treatments: Other: Direct composite restoration of carious primary anterior teeth using conventional strip crowns; Other: Direct composite restoration of carious primary anterior teeth using custom 3D printed templates

Study type: Interventional

Funder types: Other

Identifiers

NCT06478004

#841/2023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Direct resin composite using conventional strip crowns.

Active Comparator group

Description:

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

Treatment:

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