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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:
Condition or disease : Carious Teeth
Intervention/treatment:
Procedure/Surgery: 3D Printed Prefabricated composite resin crown group Procedure/Surgery: Prefabricated stainless steel crown group
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 3D Printed Prefabricated Composite Resin Crown group | Experimental | (Custom Composite Resin (Custom Resin Solutions, CRSCAM TEKNOLOJİ AŞ., ANTALYA, TURKEY) |
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| Active Comparator: Prefabricated stainless steel crown group | Experimental | Stainless Steel Crown (SSC, Kids Crown, Shinghung, Seoul, Korea) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Printed Prefabricated Composite Resin Crown Group | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of clinical success | 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 | 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 | (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) | 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
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Betül Şen Yavuz, DDS | Contact | +905399887646 | dtbetulsen@gmail.com | |
| Alp Akça, DMD | Contact | +905413386084 | galip.alpakca@marmara.edu.tr |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Prefabricated stainless steel crown group | 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. |
|
| 24 Month |
| Gingival Index (GI) (Löe & Silness, 1963) | 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) | 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 |