BioFlx Pediatric Crowns: Current Evidence on Clinical Outcomes and Material Properties
Abstract
1. Introduction
2. Materials and Methods
3. Results
3.1. In Vitro Studies
3.2. Stress Distribution and Deformation
3.3. Cement Bond Strength
3.4. Wear Resistance and Surface Properties
3.5. Fracture Resistance, Marginal Gap, and Retention
3.6. Clinical Studies
4. Discussion
5. Conclusions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study | Year | Crown Types | Test Method | Key Findings | Clinical Significance |
---|---|---|---|---|---|
Lath et al. [14] | 2024 | BioFlx (Kids e dental), SSCs, Zirconia | Load bearing capacity/shear stresses through FEA, 245 N load, multiple angles | -Maximum axial load stress: BioFlx: 14.009 MPa (lowest stress); SSCs: 39.331 MPa; Zirconia: 40.91 MPa. -All three crown types showed similar deformation patterns under simulated occlusal forces. At 90° loading, deformation was nearly identical (5.97–5.98 mm). SSCs deformed more at 45° loading (6.527 mm vs. ~5.44 mm for ZCs/BioFlx), while ZCs and BioFlx deformed more at 0° loading (~6.47 mm vs. 5.452 mm for SSCs). Load direction influenced deformation more than material type. | BioFlx crowns with a GI core material, can withstand maximum loads and could be a viable option for clinical use. [14] |
Deolikar et al. [18] | 2024 | BioFlx vs. Zirconia | FEA (von Mises stress/deformation), lateral and perpendicular forces of 245 N | Lower stress in BioFlx crowns/dentin across all load angles. Higher deformation in BioFlx vs. zirconia. | BioFlx crowns can be a suitable alternative to zirconia crowns and traditional stainless steel crowns. |
Singh et al. [27] | 2025 | BioFlx (Kids e dental), SSCs with bands | Shear bond strength testing using GIC/RMGIC cements | SSCs + RMGI: 0.908 ± 0.20 MPa; BioFlx + GIC: 0.506 ± 0.25 MPa; SSCs + GIC: 0.405 ± 0.24 MPa; BioFlx + RMGI: 0.362 ± 0.21. | SSCs perform statistically better using RMGI than GIC; they also perform better than BioFlx with RMGI; however, Bioflx crowns’ performance is statistically comparable with both cements. |
Ninawe et al. [26] | 2025 | BioFlx (Kids e dental), Zirconia, Graphene | Stress distribution and deformation capacity using FEA, 330 N vertical loading | Zirconia: 368.3 MPa (best); BioFlx: 520.92 MPa; Graphene: 555.69. | BioFlx shows moderate stress resistance and more deformation than zirconia crowns. |
Waly et al. [12] | 2025 | BioFlx with different cements (GIC, RMGI, self-cure resin cement) | FEA cement comparison | Conventional GIC best performance followed by resin cement; RMGI showed highest deformation. | Cement selection affects biomechanical behavior, with one having a higher modulus of elasticity being preferable. |
Kumari et al. [25] | 2025 | BioFlx, Zirconia, PEEK, SSCs, polycarbonate, Edelweiss | FEA, 100–330 N multiple loading | For posterior crowns under 45° oblique loading, Zirconia exhibited the highest overall stress distribution (286.90 MPa), followed by SSCs (267.80 MPa) and BioFlx (236.11 MPa). BioFlx showed the highest cement stress (214.45 MPa), while all crown types demonstrated similar deformation values (~30.17–30.21 mm). | Zirconia remains the preferred choice for long-term restorations requiring maximum strength, while BioFlx offers a viable alternative with enhanced biocompatibility and reduced stress distribution on tooth structure. The lower overall stress exhibited by BioFlx may be beneficial for compromised teeth or when minimizing stress concentration is clinically desired. |
Study | Year | Crown Types | Aging Protocol | Wear Results | Surface Properties |
---|---|---|---|---|---|
Kale et al. [28] | 2025 | BioFlx (Kids-e-dental), Zirconia | 5000 thermocycles + 120,000 mechanical load (chewing simulation) | BioFlx crowns subjected to aging exhibited significantly less volumetric wear of crown material (0.78 ± 0.36 mm) compared to zirconia crowns (1.27 ± 0.48 mm3), and significantly less wear of antagonist (0.59 ± 0.26 vs. 1.42 ± 0.49 mm3). | BioFlx crowns had significantly less mean color change values after aging than zirconia crowns (ΔE = 9.81 vs. 12.81); although both crown forms demonstrated clinically unacceptable discoloration. |
Abdou et al. [11] | 2025 | BioFlx (NuSmile), Zirconia | 5000 thermocycles + 75,000 times occlusal load (50 N) (chewing simulation) | BioFlx crowns demonstrated significantly higher volume loss than zirconia crowns (0.095 ± 0.091 vs. 0.039 ± 0.046) but significantly lower volume loss of antagonist (0.095 ± 0.091 vs. 0.534 ± 0.163). | No significant color difference between crown materials following aging and exposure to beverages (ΔE = 12.106 ± 6.216 zirconia vs. 13.864 ± 3.480 BioFlx). BioFlx: demonstrated significantly higher roughness compared to zirconia crowns (1.148 ± 0.832 vs. 0.185 ± 0.17). |
Kumari et al. [29] | 2025 | BioFlx (NuSmile), SSCs | Vertical loading, 50 N up to 100,000 chewing cycles | BioFlx crowns (0.039 ± 0.046 mm3) experienced significantly lower wear volumes compared to SSCs (0.095 ± 0.091 mm3). | Surface roughness comparable between groups (SSCs: 0.487, BioFlx: 0.466 μm). |
Study | Year | Crown Types | Test Conditions | Outcome |
---|---|---|---|---|
1-Fracture resistance and marginal gap studies | ||||
Abo-Elsoud et al. [7] | 2024 | BioFlx (NuSmile), Zirconia, SSCs | After thermomechanical aging | Fracture resistance: Stainless steel crowns demonstrated the highest fracture resistance (3062.14 ± 408.97 μm), followed by Bioflx crowns (2403.44 ± 92.65 μm), while Zirconia crowns showed the lowest (1286.30 ± 91.56 μm). Marginal gap: Zirconia crowns (62.6 ± 2.6 μm) exhibited the largest average marginal gap, followed by Bioflx (58.8 ± 6.5 μm) and stainless steel crowns (50.0 ± 1.6 μm). Failure mode: BioFlx and SSCs: Surface deformation and microperforations; Zirconia: Fracture lines. |
Kale et al. [28] | 2025 | BioFlx (Kids-e-dental), Zirconia | Before/after aging | BioFlx: Maintained adequate fracture strength after aging (1717.9 ± 328.3); Zirconia: experienced a highly significant decline in fracture strength after aging (1532.0 ± 276.2) |
2-Retention studies | ||||
Al Mawash et al. [23] | 2025 | BioFlx (NuSmile), SSCs | Resin dies, various cements (GIC, RMGI, self-adhesive resin cement, and polycarboxylate cement). | The SSCs exhibited significantly greater retention strength than BFCs across all cements, except the self-adhesive resin cement group where BioFlx crowns demonstrated superior retention (657.72 ± 20.60 N vs. 560.29 ± 8.74 N). |
Morsy et al. [24] | 2025 | BioFlx (NuSmile), Zirconia, SSCs | Natural primary teeth, thermocycling (2000 cycles) and luted with either GIC or RMGI. | Stainless steel crowns exhibited the highest retention regardless of the cement. Bioflx crowns outperformed Zirconia crowns (Bioflx: GIC = 138.11 ± 30.87 N, RMGI = 218.11 ± 34.61 N; Zirconia: GIC = 35.50 ± 5.14 N, RMGI = 131.78 ± 11.91 N). RMGI had greater retention values than GIC in BioFlx and zirconia crowns. |
Study | Year | Study Design | Sample Size | Crown Types | Luting Cement Used | Assessed Parameters | Follow-Up Period | Key Clinical Findings |
---|---|---|---|---|---|---|---|---|
Singh et al. [19] | 2025 | Split-mouth prospective RCT | 40 children (80 crowns; 40 per group) | BioFlx vs. SSCs | SSCs: GIC BioFlx: resin based cement. | -Retention -Marginal integrity -Gingival health -Overall success | 3, 6, 9, 12 months | -Retention: SSCs 100%, BioFlx 98%; -Marginal integrity: SSCs 96%, BioFlx 92%; -Overall success: SSC 95%, BioFlx 92% (p > 0.05). -BioFlx significantly higher patient satisfaction (p < 0.01); -Comparable gingival health |
Patil et al. [20] | 2024 | Split-mouth prospective RCT | 38 children (76 crowns; 38 per group) | BioFlx (Kids-e-dental) vs. SSCs | GIC | -Retention -Crown wear -Procedure time -Resistance to dislodgement before cementation -Wear of opposing -Occlusion -Marginal integrity and discoloration -Anatomic crown form -Secondary caries at margins. | 3, 6, 12 months | -Retention: SSCs achieved 100% retention while BioFlx demonstrated 92% retention (4 crowns lost). -Crown wear: No wear observed in either group through 3 months; at 12 months, BioFlx showed 12% wear versus 4% for SSCs (p > 0.05). -Procedure time: SSCs averaged 12:38 min compared to 13:54 min for BioFlx. -Resistance to dislodgement before cementation: SSCs demonstrated 88% snap fit versus 80% for BioFlx, (p > 0.05). -Wear of opposing teeth: None in either group. -Occlusion: All crowns maintained ideal or acceptable occlusion at all periods. -Marginal integrity and discoloration: all remained clinically ideal at all periods. -Anatomic crown form: SSCs demonstrated significantly more ideal anatomic form at 6 and 12 months (96%) compared to BioFlx crowns (82–86%); remaining crowns were clinically acceptable. -Secondary caries at margins: All were clinically ideal (p > 0.05). |
Abdelhafez and Dhar [21] | 2025 | Parallel RCT | 75 children (25 per group) | BioFlx (NuSmile) vs. SSCs vs. Zirconia | GIC | Postoperative pain, plaque index, crown retention (debonding rate and substance loss), and gingival index | 6, 12 months | -Postoperative pain: No significant differences were observed. -Plaque accumulation: SSCs demonstrated highest plaque scores, followed by BioFlx, then zirconia crowns at both evaluation periods (p > 0.05). -Clinical retention: SSCs followed by BioFlx crowns showed superior performance (96%) compared to zirconia crowns (92%) regarding debonding resistance at both time points (p > 0.05). BioFlx crowns exhibited the highest incidence of crown substance loss at the 6 month evaluation. -Gingival health: Zirconia crowns showed optimal gingival index scores (p > 0.05). |
Sunder et al. [22] | 2025 | Split-mouth pilot RCT | 30 children (30 per group) | SSCs vs. BioFlx | GIC | Ryge criteria, procedural time, parental satisfaction | 12 months (evaluated at baseline, 1 week, 1 month, 3 months, 6 months, 12 months) | SSCs showed significantly better staining resistance and surface integrity (p < 0.05) at 6 and 12 months. Two BioFlx crown failures (6.7%) vs. zero SSC failures at 12 months. SSCs required longer placement time (12.3 ± 1.53 min vs. 10.32 ± 1.48 min, p < 0.05). Parental preference favored BioFlx crowns. |
Goswami et al. [10] | 2024 | Case series | 3 children (1 case for each) | BioFlx (Kids-e-Dental) crowns | GIC | Discoloration, dislodgement, and gingival health | 6 months | Good retention, esthetic, and patient and parent satisfaction at 6 months; self-adaptation observed; excellent masking of SDF discoloration. |
Ruck and Gosnell [3] | 2023 | Case report | 1 case | BioFlx (NuSmile) and zirconia crowns for high caries-risk child with potential nickel allergy | GIC | Retention, color stability, plaque retention, and parental acceptance. | 3 months | BioFlx crowns demonstrated good adaptation with minor material self-adaptation noted during placement and after 3 months. Color stability was maintained on the Bioflx crowns and plaque retention was slightly higher than zirconia. Parental acceptance was equal for zirconia. Treatment was successful for addressing high caries-risk in a patient where metal restorations were contraindicated due to nickel allergy. |
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Al-Haj Ali, S.N. BioFlx Pediatric Crowns: Current Evidence on Clinical Outcomes and Material Properties. Children 2025, 12, 1281. https://doi.org/10.3390/children12101281
Al-Haj Ali SN. BioFlx Pediatric Crowns: Current Evidence on Clinical Outcomes and Material Properties. Children. 2025; 12(10):1281. https://doi.org/10.3390/children12101281
Chicago/Turabian StyleAl-Haj Ali, Sanaa N. 2025. "BioFlx Pediatric Crowns: Current Evidence on Clinical Outcomes and Material Properties" Children 12, no. 10: 1281. https://doi.org/10.3390/children12101281
APA StyleAl-Haj Ali, S. N. (2025). BioFlx Pediatric Crowns: Current Evidence on Clinical Outcomes and Material Properties. Children, 12(10), 1281. https://doi.org/10.3390/children12101281