Caries,Dental
Conditions
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.
Interventions
OTHERbioflx 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
Inclusion 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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| crown retention | 12 months | by tactile examination crown retention scoring (intact or chipped ) |
| parental satisfaction | 12 months | by a questionnaire-based five-point rating Likert's scale. from (1-5 ) 1= unsatisfied at all to 5 = very satisfied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gingival health | 12 months | scoring gingival index from (0-3) 0= indicated healthy gingiva to 3 = is severely inflamed gingiva |
| marginal integrity | 12 months | crown retention scoring ( open or closed margin ) |
| oral hygiene | 12 months | 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 |
| patient satisfaction | 12 months | by a questionnaire- based five-point rating Likert's scale. from (1-5 ) counting 1= unsatisfied at all to 5 = very satisfied |
Contacts
Primary Contacthajar ashraf abd el halim ramadan, master
Backup ContactYasmin Mohamed Yousry, PHD
Outcome results
None listed