Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars
NCT ID: NCT06706167
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2023-09-01
2024-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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stainless steel crown
Participants in this arm will receive stainless steel crowns for primary teeth.
stainless steel crown
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.
Zirconia crown
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
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
zirconia crown
Participants in this arm will receive zirconia crowns for primary teeth.
stainless steel crown
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.
Zirconia crown
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
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Bioflx crown
Participants in this arm will receive Bioflex crowns for primary teeth.
stainless steel crown
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.
Zirconia crown
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
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Interventions
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stainless steel crown
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.
Zirconia crown
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
Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.
Eligibility Criteria
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Inclusion Criteria
* Healthy children free of any systemic disease.
* Pulpotomized or pulpectomized (endodontically treated) lower second primary molars.
* Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.
Exclusion Criteria
* non-Healthy children or have any systemic disease.
* primary molars with no pulpal treatment
* Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.
3 Years
8 Years
ALL
Yes
Sponsors
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Delta University for Science and Technology
OTHER
Responsible Party
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Locations
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Delta University For Science and Technology
Gamasa, El Dakhleia, Egypt
Countries
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References
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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.
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.
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.
Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.
Dimitrov E, Georgieva M, Andreeva RJM. Indications for use of performed crowns in pediatric dentistry. 2016;2:439-45.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DU0240721024
Identifier Type: -
Identifier Source: org_study_id