Caries,Dental Clinical Trial
Official title:
Comparative Evaluation of Clinical Success,Parental and Child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars: A Randomized Clinical Study
Comparative Evaluation of Clinical Success,Parental and child Satisfaction of Bioflx Crowns Versus Stainless Steel Crowns as Restorations for Primary Molars: A Randomized Clinical Study
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | January 1, 2026 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility | Clinical Criteria: - Children from age 4-7. - Healthy children . - Cooperative children and willing for follow-up visits. - Cariouse Primary Second molars that need pulpotomy and full coverage restorations. Radiographic criteria: - Primary molars with two-thirds of the root remaining . - No widening of PDL space or loss of lamina dura continuity. - No evidence of internal/external pathologic root resorption. Exclusion Criteria: - Uncooperative child . - Handicapped children either mentally or physically. - Inability to attend follow-up visits. - Refuse to participate in the study . - Tooth with poor prognosis (unrestorable). - Teeth with root caries . - Primary teeth with more than half of the root resorbed or presence of periapical pathology seen in the radiograph . |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Cairo University |
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. — View Citation
Chakraborty, A. et al. (2017) 'Finite element stress analysis of restored primary teeth: A comparative evaluation between stainless steel crowns and preformed Zirconia Crowns', International Journal of Oral Health Sciences, 7(1), p. 10. doi:10.4103/ijohs.ijohs_18_17.
Chisini LA, Collares K, Cademartori MG, de Oliveira LJC, Conde MCM, Demarco FF, Correa MB. Restorations in primary teeth: a systematic review on survival and reasons for failures. Int J Paediatr Dent. 2018 Mar;28(2):123-139. doi: 10.1111/ipd.12346. Epub 2018 Jan 10. — View Citation
Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10. — View Citation
Harshitha, A.K. et al. (2021) 'Comparative evaluation on clinical success rate of prefabricated zirconia crowns and stainless steel crowns in primary molars', International Journal of Oral Health Dentistry, 7(3), pp. 180-186. doi:10.18231/j.ijohd.2021.036.
Kilpatrick N, Seow K, Cameron A, et al. Pulp therapy for primary and young permanent teeth. Handbook of Pediatric Dentistry. 2003;2:71-86. [Google Scholar]
Malekzadeh Shafaroudi, A., Nasiri, P. and Nahvi, A. (2021) 'Nickel sensitivity in children due to using stainless steel crowns: A narrative review', Journal of Pediatrics Review, 9(2), pp. 145-152. doi:10.32598/jpr.9.2.870.2.
Mohn M, Frankenberger R, Kramer N. Wear and marginal quality of aesthetic crowns for primary molars. Int J Paediatr Dent. 2022 Mar;32(2):273-283. doi: 10.1111/ipd.12852. Epub 2021 Jul 29. — View Citation
Nikhil, D.K. et al. (2022) 'Clinical evaluation of Zirconia and stainless-steel crowns in primary molars - a randomized control trial', International Journal of Pedodontic Rehabilitation, 7(2), pp. 30-38. doi:10.56501/intjpedorehab.v7i2.571.
O'Connell AC, Kratunova E, Leith R. Posterior preveneered stainless steel crowns: clinical performance after three years. Pediatr Dent. 2014 May-Jun;36(3):254-8. — View Citation
Patel, M. et al. (2022) 'Clinical evaluation and parental and child satisfaction with restoration of primary teeth using zirconia and stainless steel crowns: A randomized clinical study', Advances in Human Biology, 0(0), p. 0. doi:10.4103/aihb.aihb_43_22.
Salman, N. et al. (2021a) 'Parental satisfaction regarding two types of commercial crowns for restoring pulpotomized primary molars', Egyptian Dental Journal, 67(4), pp. 2915-2921. doi:10.21608/edj.2021.93279.1775.
Waly AS, Souror YR, Yousief SA, Alqahtani WMS, El-Anwar MI. Pediatric Stainless-Steel Crown Cementation Finite Element Study. Eur J Dent. 2021 Feb;15(1):77-83. doi: 10.1055/s-0040-1715915. Epub 2020 Oct 1. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | crown retention | by tactile examination crown retention scoring (intact or chipped ) | 12 months | |
Primary | parental satisfaction | by a questionnaire-based five-point rating Likert's scale. from (1-5 ) 1= unsatisfied at all to 5 = very satisfied | 12 months | |
Secondary | marginal integrity | crown retention scoring ( open or closed margin ) | 12 months | |
Secondary | gingival health | scoring gingival index from (0-3) 0= indicated healthy gingiva to 3 = is severely inflamed gingiva | 12 months | |
Secondary | oral hygiene | by visual clinical examination and score in oral hygiene index (0- 3) 0 =No debris 3 = Soft tissue debris covering more than two third of tooth surface | 12 months | |
Secondary | patient satisfaction | by a questionnaire- based five-point rating Likert's scale. from (1-5 ) counting 1= unsatisfied at all to 5 = very satisfied | 12 months |
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