Clinical trial NCT06396195: Comparative Evaluation of Bioflx Crowns vs Stainless Steel Crowns
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caries,Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 28
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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 .

Primary outcomes:
measure: crown retention
timeFrame: 12 months
measure: parental satisfaction
timeFrame: 12 months
Secondary outcomes:
measure: marginal integrity
timeFrame: 12 months
measure: gingival health
timeFrame: 12 months
measure: oral hygiene
timeFrame: 12 months
measure: patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Adel Abdel Azeem ElBardissy, professor
role: STUDY_DIRECTOR
References:
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