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Today, with increasing aesthetic demands; the need for materials that are both durable and compatible with the appearance of natural teeth is increasing in paediatric dentistry. Prefabricated zirconium crowns have attracted significant interest in recent years because they meet aesthetic expectations and have offer mechanical strength. There are various traditional and contemporary cement options that can be used for cementation of crowns.
The aim of this study is to clinically evaluate prefabricated zirconia crowns cemented to the primary maxillary incisors with three different adhesive cements in terms of periodantal health, plaque accumulation, opposing tooth wear, parental satisfaction, color harmony, retention, marginal integrity and contact compatibility, at the 1-week, 3-month, 6-month, 12-month follow-ups.
The sample size was calculated as 30 with the G*Power analysis program. Considering the case losses, the sample size will be increased by 20% and a total of 36 teeth will be included. In the study, 3 different cements will be applied to each cement group, 12 teeth.
In this study, 36 teeth will be included from patients aged 3-4 years who have two or more surface carious lesions on their maxillary incisors. After necessary caries removal and pulpectomy treatment, prefabricated zirconia crowns will be prepared and cemented under general anesthesia, using one of three randomly selected cements.
12 teeth will be cemented with FujiCEM Evolve (GC, Tokyo, Japan) 12 teeth with RelyX U200 (3M ESPE, St. Paul, USA) 12 teeth with Ketac Cem (3M ESPE, USA) Patients will be called for follow-up examinations one week after the completion of all dental treatments and at 3, 6, and 12 months. During these follow-ups, Gingival Index, Plaque Index, Tooth Wear Index, and Ryge (USPHS) Criteria will be evaluated on the teeth, and a parental satisfaction scale will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| glass ionomer cement | Experimental | Prefabricated zirconia crowns cemented with glass ionomer cement (Ketac Cem (3M ESPE, USA)) on primary maxillary incisors will be clinically evaluated at 1-week, 3-month, 6-month, and 12-month follow-ups in terms of periodontal health, plaque accumulation, wear of opposing teeth, parental satisfaction, color match, retention, marginal integrity, and contact harmony |
|
| dual-cure self-adhesive resin cement | Experimental | Prefabricated zirconia crowns will be cemented with dual-cure self-adhesive resin cement (RelyX U200 (3M ESPE, St. Paul, USA)) on primary maxillary incisors and will be evaluated during follow-up sessions. |
|
| resin modified glass ionomer cement | Experimental | Prefabricated zirconia crowns will be cemented with resin modified glass ionomer cement (FujiCEM Evolve (GC, Tokyo, Japan)) on primary maxillary incisors and will be evaluated during follow-up sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glass ionomer cement | Drug | A cement used for crown cementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical performance. | Modified United States Public Health Service (USPHS) criteria will be used to evaluate retention, marginal integrity, secondary caries, color match, and crown fracture. Restorations are evaluated using an alphabetical grading scale. When assessing based on specific criteria: Alpha (A), represents ideal restorations, Bravo (B), denotes restorations that are not ideal but remain within acceptable limits, Charlie (C), refers to restorations that fall outside clinically acceptable boundaries and require replacement, Delta (D) is assigned to restorations that are either currently mobile or causing damage to surrounding tissues. | 1 week, 3 months, 6 months, 12 months |
| Change in periodontal health (Plaque) | Periodontal health will be assessed using the Plaque index (PI). Each of the four surfaces of a tooth will be assigned an index score from 0 to 3 based on the amount of plaque observed: 0: No plaque is present.
| 1 week, 3 months, 6 months, 12 months |
| Wear of opposing natural teeth | The Smith and Knight Tooth Wear Index classification, which is used to grade tooth wear, will be applied. The incisal surfaces of all teeth will be examined. Score 0: (Buccal/Lingual/Occlusal/Incisal): No loss of enamel surface characteristics. (Cervical): No loss of contour. Score 1: (B/L/O/I): Loss of enamel surface characteristics. (C): Minimal loss of contour. Score 2: (B/L/O): Loss of enamel exposing dentine for less than one third of surface. (I): Loss of enamel just exposing dentine. (C): Defect less than 1 mm deep. Score 3: (B/L/O): Loss of enamel exposing dentine for more than one third of surface. (I): Loss of enamel and substantial loss of dentine (C): Defect less than 1-2 mm deep. Score 4: (B/L/O): Complete enamel loss-pulp exposure- secondary dentin exposure. (I): Pulp exposure or exposure of secondary dentine. (C): Defect more than 2 mm deep-pulp exposure- secondary dentine exposure. |
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Inclusion Criteria:
Exclusion Criteria:
Those who wish to withdraw from the study at any stage will be excluded from the study.
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| Name | Affiliation | Role |
|---|---|---|
| Kadriye Görkem Ulu Güzel, Assoc. Prof. | gorkemulu@yahoo.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydin Adnan Menderes University | Aydin | Efeler | 09100 | Turkey (Türkiye) |
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Individual Patient Data (IPD) will not be shared with other researchers
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005899 | Glass Ionomer Cements |
| C040235 | Ketac-cem |
| C587242 | RelyX U200 |
| ID | Term |
|---|---|
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
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| self-adhesive resin cement | Drug | A cement used for crown cementation |
|
|
| resin modified glass ionomer cement | Drug | A cement used for crown cementation |
|
|
| 1 week, 3 months, 6 months, 12 months |
| Measuring of parental satisfaction | Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.
| 1 week, 3 months, 6 months, 12 months |
| Change in periodontal health (Gingiva) | Periodontal health will be assessed using the Gingival index (GI). The degree of inflammation and bleeding at each of the four surfaces of a tooth will be assessed using the following index system: 0: No visible signs of inflammation.
| 1 week, 3 months, 6 months, 12 months |
| 14158464 | Background | SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available. |
| 14121956 | Background | LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available. |
| 27608199 | Background | Cohn C. Zirconia-Prefabricated Crowns for Pediatric Patients With Primary Dentition: Technique and Cementation for Esthetic Outcomes. Compend Contin Educ Dent. 2016 Sep;37(8):554-8. |
| 37106541 | Background | Srinivasan SR, Mathew MG, Jayaraman J. Comparison of Three Luting Cements for Prefabricated Zirconia Crowns in Primary Molar Teeth: a 36-month Randomized Clinical Trial. Pediatr Dent. 2023 Mar 15;45(2):117-124. |
| 33772904 | Background | Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25. |
| 35270531 | Background | Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838. |
| D013676 |
| Technology, Industry, and Agriculture |