Comparative Evaluation of Bioflx Crowns vs Stainless Steel Crowns

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396195
• Other study ID #: bioflx vs ssc
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: hajar ashraf abd el halim ramadan, master
• Phone: 01205789999
• Email: hajar.ashraf[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

In the field of pediatric dentistry, various materials can be utilized to treat decayed primary teeth, such as composites, glass ionomer cements, or steel crowns. Despite demonstrating acceptable properties, numerous failures are consistently documented, predominantly linked to issues like secondary caries.

Over the course of time, a variety of full-coverage dental restorations have been introduced and integrated into pediatric dental care. Stainless-steel crowns (SSCs) have emerged as the most widely accepted and frequently utilized full-coverage restoration for both primary and permanent teeth in children. Since the 1950s, pediatric dentists globally have favored SSCs due to their exceptional durability, secure cervical fit, cost-effectiveness, and the fact that they require minimal technique sensitivity during the restoration process.

Stainless steel crowns (SSCs) offer robust and dependable full-coverage restorations, remaining in place throughout the lifespan of a primary tooth. However, a notable drawback is the unfavorable metallic appearance, which is disliked by both parents and children. Numerous efforts have been made to develop alternative esthetic substitutes for SSCs, such as composite, polycarbonate, thermoformed plastic, and zirconia.

As the emphasis on esthetics in children has grown, technological progress has successfully brought about the introduction of prefabricated zirconia crowns (ZCs). The adoption of zirconia crowns for primary dentition began in 2008. While zirconia crowns share mechanical properties with metal, they necessitate greater tooth reduction.

The Bioflx crowns are characterized by their flexibility, durability, and adaptability. These crowns are preformed pediatric crowns designed for aesthetics, combining properties found in both stainless steel and zirconia crowns. However, there is a notable absence of scholarly evidence evaluating the properties of Bioflx crowns and their impact on clinical outcomes and parental satisfaction when compared to conventional options. Consequently, this study aims to examine the clinical performance of Bioflx crowns and traditional stainless steel crowns (SSCs) in pediatric patients, with a focus on assessing child and parental satisfaction.

Recruitment information / eligibility

• 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 .

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Other:
• bioflx crown
The Bioflx crowns are characterized by their flexibility, durability, and adaptability. These crowns are preformed pediatric crowns designed for aesthetics, combining properties found in both stainless steel and zirconia crowns.
• stainless steel crown
Stainless steel crowns continue to be considered the "Gold Standard" for posterior full coverage restorations in primary molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (13)

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

Outcome

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