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The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown.
the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stainless steel crown | Active Comparator | Participants in this arm will receive stainless steel crowns for primary teeth. |
|
| zirconia crown | Experimental | Participants in this arm will receive zirconia crowns for primary teeth. |
|
| Bioflx crown | Experimental | Participants in this arm will receive Bioflex crowns for primary teeth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stainless steel crown | Device | Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque accumulation | Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| crown retention | Assessed using the USPHS criteria, where "Alpha" indicated the crown was continuous with the existing anatomic form, "Bravo" indicated a missing part of the crown but not enough to expose the underlying dentin/base, and "Charlie" indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown | 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival health | Evaluated using the bleeding index according to Löe and Silness (1963), with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation). | 6 months and 12 months |
Inclusion Criteria:
Exclusion Criteria:
• Patient younger than 3 years old or older than 8 years old.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta University For Science and Technology | Gamasa | El Dakhleia | 11152 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25631720 | Result | Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g. | |
| 33845821 | Result | Uhlen MM, Tseveenjav B, Wuollet E, Furuholm J, Ansteinsson V, Mulic A, Valen H. Stainless-steel crowns in children: Norwegian and Finnish dentists' knowledge, practice and challenges. BMC Oral Health. 2021 Apr 12;21(1):190. doi: 10.1186/s12903-021-01556-6. |
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We are currently reviewing the potential for sharing individual participant data (IPD) following the completion of the study. Factors such as data privacy, participant consent, and regulatory guidelines are being considered. A final decision on data sharing will be made at the conclusion of the study, and the IPD sharing plan will be updated accordingly
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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This research was designed as a randomized controlled trial conducted by a single operator to minimize operator-induced errors. A total sample of 75 primary molars was determined, allowing for potential dropouts, and was evenly distributed into three groups of 25. Each group recieved different crown, groups A for stianless steel crown, group B for zirconia crown and group C for Bioflx crown. At 6 and 12 months follow up, each crown was evaluated clinically such as plaque index , crown retentivity and gingival index.
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| Zirconia crown | Device | Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel. |
|
| Bioflx crown | Device | Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns. |
|
| 24994618 | Result | Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30. |
| 25905656 | Result | Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60. |
| Result | Dimitrov E, Georgieva M, Andreeva RJM. Indications for use of performed crowns in pediatric dentistry. 2016;2:439-45. |
| 23550521 | Result | Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12. |
| 35830632 | Result | Aggarwal P, Goyel V, Mathur S, Sachdev V. Effect of Stainless-Steel Crown and Preformed Zirconia Crown on the Periodontal Health of Endodontically Treated Primary Molars Correlating with IL-1beta: An In Vivo Study. J Clin Pediatr Dent. 2022 May 1;46(3):199-203. doi: 10.17796/1053-4625-46.3.5. |
| 33723119 | Result | Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20. |
| 27377108 | Result | Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12. |
| 33790544 | Result | Kopczynski K, Meyer BD. Examining Parental Treatment Decisions Within a Contemporary Pediatric Dentistry Private Practice. Patient Prefer Adherence. 2021 Mar 25;15:645-652. doi: 10.2147/PPA.S300684. eCollection 2021. |
| 40251538 | Derived | Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8. |