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Evaluation and understanding of clinical success, parental satisfaction and effects on periodontal tissues are the main expected benefits of prefabricated zirconia crowns and prefabricated stainless steel crowns. For a long time, stainless steel crowns have been the restorative material of choice for children's primary and permanent posterior teeth. Today, prefabricated zirconia crowns are more popular than other options because they meet aesthetic expectations and have high mechanical strength. The aim of this study is to evaluate and compare the periodontal health, plaque accumulation, opposing tooth wear, parental satisfaction, and clinical performance (color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity) of pediatric prefabricated stainless steel and zirconia crowns applied after pulpotomy to asymptomatic, multifaceted, deep carious primary mandibular second molars.
MATERIALS AND METHODS/RESEARCH TECHNIQUES:
Material:
In the study, two different prefabricated crowns will be applied to the right and left primary mandibular second molars after pulpotomy using a split-mouth design. One will be a prefabricated zirconia crown and the other will be a prefabricated stainless steel crown. The sample size was calculated by G*Power analysis program as 12 teeth, 6 teeth in each group. Since this sample size would reduce the validity and reliability of future statistical tests, it was decided to conduct the study with a total of 20 samples, 10 in each group, taking into account possible data loss and the power of the study. Teeth will be randomly divided into two groups according to crown type.
The study will be terminated when the last visit of the last patient providing the sample is completed and the data is finalized.
Method:
In general, in the evaluation of success:
Plaque Index and Gingival Index in pediatric prefabricated stainless steel and zirconia crowns applied to asymptomatic primary mandibular second molars after pulpotomy will be evaluated at baseline and at the 1-month, 3-month, 6-month, and 12-month follow-ups. Tooth Wear Index, Modified United States Public Health Service (USPHS) Criteria, and parental satisfaction will also be assessed at the 1-month, 3-month, 6-month and 12-month follow-ups. Intraoral photographs will be taken immediately after treatment and at each follow-up appointment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prefabricated stainless steel crowns (Group A) | Experimental | Groups that received prefabricated stainless steel crowns |
|
| Prefabricated zirconia crowns (Group B) | Experimental | Groups that received prefabricated zirconia crowns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prefabricated stainless steel crowns | Other | Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in periodontal health (Gingiva) | Gingival evaluation of the patients will be made according to the Loe and Silness Gingival Index. According to this index system: 0 : Normal (absence of inflammation)
| baseline, 1 months, 3 months, 6 months, 12 months |
| Change in periodontal health (Plaque) | Plaque evaluation of the patients will be performed according to Silness and Loe Plaque Index. After the teeth isolated with cotton before the evaluation are air dried, the amount of plaque in the area near the gingival margin of each tooth will be examined by inspection and examination probe. According to this index system:: 0: No plaque.
| baseline, 1 months, 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 Smith and Knight Tooth Wear Index criteria are as follows: 0 Points (Buccal/lingual/occlusal/incisal): No loss of enamel surface characteristics (Cervical): No contour loss. Score 1 (Buccal/lingual/occlusal/incisal): Loss of enamel surface features (cervical): Minimal contour loss. Score 2 (Buccal/lingual/occlusal): Dentin opening with enamel loss of less than 1/3 of the surface (incisal): Dentin exposure with enamel loss (cervical): Less than 1 mm defect. Score 3 (Buccal/lingual/occlusal): More than 1/3 of the dentin surface exposed with enamel loss (incisal): Enamel loss and significant dentin loss (cervical): 1-2 mm defect. Score 4 (Buccal/lingual/occlusal): Complete loss of enamel or exposure of pulp/secondary dentin (incisal): Opening of pulp or secondary dentin (cervical): Defect larger than 2 mm or pulp/secondary dentin dehiscence. |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring of parental satisfaction | Parental satisfaction will be evaluated on a five-point Likert scale, which responders specify their level of satisfaction.
| 1 months, 3 months, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kadriye Görkem Ulu Güzel, Doç. Prof | Contact | 505-764-6372 | gorkem.ulu@adu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Kadriye Görkem Ulu Güzel, Doç. Prof. | Adnan Menderes Üniversitesi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adnan Menderes University | Recruiting | Aydin | Aydın | 09100 | Turkey (Türkiye) |
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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| prefabricated zirconia crowns | Other | Full coverage restoration after pulpal treatment in multi-surface deep caries of primary mandibular second molars requiring pulpotomy |
|
| 1 months, 3 months, 6 months, 12 months |
| Change in clinical performance | Modified United States Public Health Service (USPHS) criteria will be used to evaluate color match, retention, marginal integrity, marginal discoloration, anatomic form, secondary caries, surface roughness, surface gloss and postoperative sensitivity. Restorations are evaluated and scored alphabetically. When evaluated in terms of any criterion; A: ideal restorations, B: restorations that are not ideal but within acceptable limits, C: restorations that are clinically unacceptable and need to be replaced, D: restorations that are already mobile or damage tissues receive a score of D. During clinical examination and recording, phonetically similar nomenclature is used to avoid misunderstanding of the score in terms of the letter pronounced by the physician: 'A'lfa, 'B'ravo, 'C'harlie, 'D'elta. | 1 months, 3 months, 6 months, 12 months |