An interventional study of bioflx crown and stainless steel crown in Caries,Dental, sponsored by Cairo University. Not yet recruiting. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 28 is below the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Clinical Criteria:
Radiographic criteria:
Exclusion Criteria:
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
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
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 crowns continue to be considered the "Gold Standard" for posterior full coverage restorations in primary molars
Also known as: ssc
crown retention
by tactile examination crown retention scoring (intact or chipped )
Time frame: 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
Time frame: 12 months
marginal integrity
crown retention scoring ( open or closed margin )
Time frame: 12 months
gingival health
scoring gingival index from (0-3) 0= indicated healthy gingiva to 3 = is severely inflamed gingiva
Time frame: 12 months
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
Time frame: 12 months
patient satisfaction
by a questionnaire- based five-point rating Likert's scale. from (1-5 ) counting 1= unsatisfied at all to 5 = very satisfied
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
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Cairo University