Comparison of 3D Printed Composite Resin Crowns With Stainless Steel Crowns

Marmara University

Status: Not yet enrolling

Conditions: Carious Teeth

Treatments: Procedure: 3D Printed Prefabricated Composite Resin Crown Group; Procedure: Prefabricated stainless steel crown group

Study type: Interventional

Funder types: Other

Identifiers

NCT06161103

MUPediatricDentistry 3D Crown

Details and patient eligibility

About

The goal of this splith - mouth clinical trial is to compare 3D Printed Prefabric Composite Resin Crowns with Stainless Steel Crowns in healthy 50 children age between 5 and 9 with caries on more than one surface of the primary second molars.

The main question[s] it aims to answer are:

• 3D printed composite resin crown's survival rate is as succesful as stainless steel crowns
• 3D printed composite resin crowns periodontal integrity is as succesful as stainless steel crowns

Condition or disease : Carious Teeth

Intervention/treatment:

Procedure/Surgery: 3D Printed Prefabricated composite resin crown group Procedure/Surgery: Prefabricated stainless steel crown group

Full description

In this study, 3D Printed prefabricated composite resin crowns will be compared with prefabricated stainless steel crowns in a randomized controlled manner. The study will be conducted in split-mouth to eliminate the effect of potential confounders. The obtained data will be analyzed using appropriate statistical methods.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 5-9 years with caries on second primary molars
• Children without systemic disease or developmental dental anomalies that may affect caries susceptibility.
• Children whose cooperation is 'positive' or 'absolutely positive' according to the Frankl behavioral scale (Frankl et al., 1962).
• Those with deep dentin caries that do not extend to the pulp in the teeth to be treated
• The molars will be treated with a crown indication.
• Presence of symmetry of the primary molar to be treated in the opposite arch.
• The molar to be treated is in occlusion with the antagonist.
• Presence of caries on at least two surfaces of the molars to be treated.
• Absence of spontaneous pain, abscess, mobility, interradicular lesion in the tooth to be treated
• Patients whose parents and themselves agree to participate in the treatment

Exclusion criteria

• Children whose treatment cannot be continued on the dental chair due to cooperation
• Molars that will soon be exfoliated, 1/2 of the root has been resorbed
• The presence of bruxism
• The presence of erosion or attrition-related wear on the opposing molar
• The patient does not come to the control appointment or does not want to continue to the research
• Have allergy to local anesthetic, nickel or chromium
• Complications during treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Experimental: 3D Printed Prefabricated Composite Resin Crown group

Experimental group

Description:

(Custom Composite Resin (Custom Resin Solutions, CRSCAM TEKNOLOJİ AŞ., ANTALYA, TURKEY)

Treatment:

Procedure: 3D Printed Prefabricated Composite Resin Crown Group

Active Comparator: Prefabricated stainless steel crown group

Experimental group

Description:

Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)

Treatment:

Procedure: Prefabricated stainless steel crown group