Comparative Evaluation of Bioflx Crowns vs Stainless Steel Crowns

Cairo University (CU)

Status: Not yet enrolling

Conditions: Caries,Dental

Treatments: Other: bioflx crown; Other: stainless steel crown

Study type: Interventional

Funder types: Other

Identifiers

NCT06396195

bioflx vs ssc

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

stainless steel crown

Active Comparator group

Description:

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.

Treatment:

Other: stainless steel crown

bioflx crown

Active Comparator group

Description:

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

Treatment:

Other: bioflx crown