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

NCT ID: NCT06161103

Last Updated: 2023-12-07

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Carious Teeth

Keywords

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3D printing, stainless steel crowns, composite resin crowns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: 3D Printed Prefabricated Composite Resin Crown group

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

Group Type EXPERIMENTAL

3D Printed Prefabricated Composite Resin Crown Group

Intervention Type PROCEDURE

3D Crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).

Active Comparator: Prefabricated stainless steel crown group

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

Group Type EXPERIMENTAL

Prefabricated stainless steel crown group

Intervention Type PROCEDURE

Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.

Interventions

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3D Printed Prefabricated Composite Resin Crown Group

3D Crown application: After preparing the molars, the crown was cemented by passive seating with modified glass ionomer cement (GC FujiCEM Evolve, GC America, Alsip, USA).

Intervention Type PROCEDURE

Prefabricated stainless steel crown group

Stainless steel crown application: After preparing the molars, the crown was filled with type-1 glass ionomer cement (Aqua Meron, Voco, Cuxhaven, Germany) and cemented.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Betül Şen Yavuz, DDS

Role: CONTACT

Phone: +905399887646

Email: [email protected]

Alp Akça, DMD

Role: CONTACT

Phone: +905413386084

Email: [email protected]

Other Identifiers

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MUPediatricDentistry 3D Crown

Identifier Type: -

Identifier Source: org_study_id