Comparative Evaluation of Bioflx Crowns vs Stainless Steel Crowns

NCT06396195 | Not Yet Recruiting

• 1 other identifier: bioflx vs ssc
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (2)

• crown retention

  by tactile examination crown retention scoring (intact or chipped )

  12 months

• 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 Outcomes (4)

• marginal integrity

  12 months

• gingival health

  12 months

• oral hygiene

  12 months

• patient satisfaction

  12 months

Study Arms (2)

stainless steel crown

ACTIVE COMPARATOR

Tooth preparation will involve using a tapered diamond bur to reduce the occlusal surface by 1-1.5mm. Special attention will be given to ensure a consistent occlusal reduction. Interproximal reduction will be carried out distally using a tapered diamond bur, with the rounding of line angles and achieving a knife-edge finish margin on the proximal surface while avoiding any ledge formation. For crown selection, an appropriately sized crown will be chosen based on the mesiodistal width of the prepared tooth, and a trial fit will be performed to prevent blanching before cementation. The crown will be contoured and crimped using crown-contouring and crimping pliers. Afterward, the crown will be smoothed and polished along the entire margin using a rubber wheel. Finally, the crown will be cemented using type 1 Glass ionomer luting cement (Prevest Denpro, India ), and any excess material will be removed with an explorer. The final occlusion will be then verified.

Other: stainless steel crown

bioflx crown

ACTIVE COMPARATOR

Prior to preparation ,selection of crown size will be done by occlusal to occlusal comparison \- we will maintain cusp inclines and reduce the occlusal by 1-1.5 mm , including the central groove(Tip of football diamond ) buccal and lingual occlusal third of clinical crown will be reduced by football diamond proximal contact will be opened with adjacent teeth by 0.5 mm, creating a feather edge gingival margin ( tip of black stripe diamond ) Roundation all line angles will be done Buccal bulge reduction will be done while maintaining a snug fit Trial fit the crown. Seating direction will be lingual to buccal . Adjustment of the preparation as needed for snug /active fit which should provide some resistance to dislodgement Glass ionomer luting cement (Prevest Denpro, India ) will be used to cement the crown

Other: bioflx crown

Interventions

bioflx crown OTHER

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.

bioflx crown

stainless steel crown OTHER

Stainless steel crowns continue to be considered the "Gold Standard" for posterior full coverage restorations in primary molars

Also known as: ssc

stainless steel crown

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

Related 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.

  PMID: 35830632 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29322626 BACKGROUND

• 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.

  PMID: 24913609 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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]

  BACKGROUND

• 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.

  PMID: 34138501 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24960395 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33003242 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Adel Abdel Azeem ElBardissy, professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

hajar ashraf abd el halim ramadan, master

CONTACT

01205789999; hajar.ashraf@dentistry.cu.edu.eg

Yasmin Mohamed Yousry, PHD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hajar Ashraf

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: May 2, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share