Early Childhood Caries, Dental Caries, Pulp-Treated Primary Molars
Conditions
Keywords
Bioflx Crown, Stainless Steel Crown, Pulpotomy, Pediatric Dentistry, T-Scan
Brief summary
this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.
Detailed description
Early childhood caries commonly affects primary molars and often requires full-coverage restoration after pulp therapy. Stainless steel crowns are widely used because of their durability and clinical success, but they may have limitations related to esthetics and acceptance. Bioflx crowns are a more esthetic and flexible alternative, but there is limited evidence comparing their functional performance with stainless steel crowns. This parallel randomized controlled trial will be conducted at the outpatient clinic of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. A total of 18 children with pulp-treated primary molars will be enrolled and randomly allocated in a 1:1 ratio to receive either a Bioflx crown or a stainless steel crown. The primary outcome is vertical dimension alteration measured in millimetres using a digital caliper. Secondary outcomes include mean biting force distribution measured by T-Scan digital occlusal analysis, parental satisfaction with esthetics, and parental satisfaction with treatment impact assessed by 5-point Likert scale questionnaires. Outcome measurements will be recorded at baseline, immediately after crown placement, at 1 week, and at 4 weeks, with parental satisfaction assessed at 4 weeks. The purpose of this study is to determine whether Bioflx crowns provide comparable or improved functional and esthetic outcomes compared with stainless steel crowns in pulp-treated primary molars.
Interventions
DEVICEBioflx Crown
Aesthetic full-coverage pediatric crown used after pulp therapy of primary molars. The Bioflx crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement.
DEVICEStainless Steel Crown
Preformed stainless steel full-coverage pediatric crown used after pulp therapy of primary molars. The stainless steel crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and the operator are not blinded because of differences between the crown materials and their preparation. The statistician will be blinded.
Intervention model description
Two-arm parallel randomized controlled trial in which participants are assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown.
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* Pulp-treated primary molars (pulpotomy) * Asymptomatic teeth after pulp therapy with no signs of infection, mobility, or radiographic pathology, such as internal resorption or periapical lesions * Age 6 years to 9 years * Male or female * Cooperative child with positive Frankl behavior rating * No missing teeth * Normal occlusion, including normal overjet and overbite * Free from systemic disease to allow continuity of follow-up
Exclusion criteria
* Medically compromised or uncooperative children * Tooth indicated for extraction because of root resorption, teeth near exfoliation, or deep subgingival caries that prevents proper coronal seal * Teeth with more than two-thirds root resorption * Previous pulp therapy * Parafunctional habits, including bruxism, thumb-sucking, or other habits that may affect occlusal force measurements * Inability to attend follow-up visits or parental refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical dimension alterations | Baseline, immediately after crown placement, 1 week, and 4 weeks | Change in inter-occlusal vertical dimension measured in millimetres using a digital caliper at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Mean differences will be compared between the Bioflx crown group and the stainless steel crown group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Biting Force Distribution | Baseline, immediately after crown placement, 1 week, and 4 weeks | Occlusal force distribution on the restored tooth measured as a percentage using T-Scan digital occlusal analysis at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Force distribution will be compared between the Bioflx crown group and the stainless steel crown group. |
| Parental Satisfaction With Treatment Impact | 4 weeks | Parental ratings of the impact of treatment on the child, including comfort, chewing ability, well-being, and perceived improvement in appearance, assessed using a 5-point Likert scale questionnaire. |
Countries
Egypt
Contacts
CONTACTEman A Hassan, BDS
CONTACTOsama A El Shahawy, PHD
PRINCIPAL_INVESTIGATOROsama A El shahawy, PHD
Cairo University
Outcome results
None listed