- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06161103
Comparison of 3D Printed Composite Resin Crowns With Stainless Steel Crowns
Comparison of the Clinical Success of 3D Printed Prefabricated Composite Resin Crowns With Stainless Steel Crowns: A Randomised Controlled Trial
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Betül Şen Yavuz, DDS
- Phone Number: +905399887646
- Email: dtbetulsen@gmail.com
Study Contact Backup
- Name: Alp Akça, DMD
- Phone Number: +905413386084
- Email: galip.alpakca@marmara.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: 3D Printed Prefabricated Composite Resin Crown group
(Custom Composite Resin (Custom Resin Solutions, CRSCAM TEKNOLOJİ AŞ., ANTALYA, TURKEY)
|
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).
|
Experimental: Active Comparator: Prefabricated stainless steel crown group
Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea)
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of clinical success
Time Frame: 24 Month
|
According to the criteria reported by Santamaria et al. (2004), clinical success will be categorized as successful, major failure, and minor failure. Successful: No clinical signs or symptoms of pulp pathology Tooth has exfoliated (without any minor/major failures) No deformations in the crown/restoration No pathology observed in radiographs Minor failure: Reversible pulpitis (No need for root canal treatment or extraction) Crown/restoration loss that can be restored Presence of deformations/fractures/perforations in the crown/restoration Permanent crown remaining submerged Presence of new caries at the margins Major failure: Irreversible pulpitis Crown/restoration loss that cannot be restored Inter-radicular radiolucency Internal root resorption |
24 Month
|
United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria
Time Frame: 24 Month
|
Restorations were evaluated to determine success according to modified United States Public Health Service (USPHS) criteria for marginal adaptation, marginal discolouration, secondary caries, anatomical form, retention, postoperative sensitivity and colour matching.
Restorations with an "Alpha (A)" score were considered successful, those with a "Bravo (B)" score were considered acceptable, and those with a "Charlie (C)" score were considered unsuccessful.
The scoring of the restorations was decided by agreement of both dentists (Ryge G. et al., 1980).
|
24 Month
|
Marginal Crown Gap
Time Frame: 24 Month
|
(0) ¼ at the gingival margin, (1) ¼ below the gingival line (apical to the gingival margin) or (2) ¼ above the gingival line (occlusal to the gingival margin) [Muhamed Altinawia et al., 1980].
|
24 Month
|
Plaque Index (PI) (Silness and Loe, 1964)
Time Frame: 24 Month
|
In this index, the thickness of dental plaque on the mesial, distal, vestibular, lingual tooth surfaces of all teeth or selected teeth and in relation to the gingiva is evaluated by probing. The values determined on the surfaces are summed and the plaque index value of the individual is obtained by taking the mathematical average. 0-No plaque in the area adjacent to the gingiva
|
24 Month
|
Gingival Index (GI) (Löe & Silness, 1963)
Time Frame: 24 Month
|
It evaluates bleeding, which is the most basic sign of inflammation. The mesial, distal, vestibule and lingual sides of the teeth are evaluated. These values are then summed and divided by four. 0- Healthy gingiva, no inflammation
|
24 Month
|
Simplified Oral Hygiene Index (OHI-S)
Time Frame: 24 Month
|
Simplified Oral Hygiene Index (OHI-S) will be used to evaluate the plaque and calculus deposits of the patient and control groups. In this index, in order to simplify the oral hygiene index, six index teeth, which are considered representative of all anterior and posterior teeth, are evaluated. These teeth are teeth numbered 16, 26, 11, 31, 36, 46. The facial surfaces of teeth 16-26-11-31 and the lingual surfaces of teeth 36-46 are evaluated. This facilitation process is used both in the calculation of the debris index and in the calculation of the calculus index. After calculating the debris and calculus assessment indices, a simplified oral hygiene index is obtained (REF: 29.Greene, J.C., Vermillion, J.R.: The Simplified Oral Hygiene Index, J. Amer. Dent. Ass 68 : 7, 1960). The Simplified Oral Hygiene Index (OHI-S) Debris Index 0- No debris.
|
24 Month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUPediatricDentistry 3D Crown
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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