Clinical trial NCT06161103: Comparison of 3D Printed Composite Resin Crowns With Stainless Steel Crowns
Official title: Comparison of the Clinical Success of 3D Printed Prefabricated Composite Resin Crowns With Stainless Steel Crowns: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carious Teeth
Keywords: 3D printing, stainless steel crowns, composite resin crowns
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of clinical success
timeFrame: 24 Month
measure: United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria
timeFrame: 24 Month
measure: Marginal Crown Gap
timeFrame: 24 Month
measure: Plaque Index (PI) (Silness and Loe, 1964)
timeFrame: 24 Month
measure: Gingival Index (GI) (Löe & Silness, 1963)
timeFrame: 24 Month
measure: Simplified Oral Hygiene Index (OHI-S)
timeFrame: 24 Month
Secondary outcomes:
Other outcomes:
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Study officials:
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