Clinical trial NCT06478004: Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates
Official title: Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates: A 12-Month Parallel Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Teeth
Keywords: Early childhood caries
Strip Crown
3D Printing
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Surface luster
timeFrame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
measure: Anatomical form
timeFrame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
measure: Material fracture
timeFrame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
measure: Marginal adaptation
timeFrame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
measure: Periodontal response
timeFrame: On three occasions; a week after placement (T0), at six months (T1), and at twelve months (T2)
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
affiliation: Faculty of Dentistry, Minia University, Minia, Egypt.
name: Mina Yassa, Doctor
role: PRINCIPAL_INVESTIGATOR
References: