Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioflx Crown Group | Experimental | Participants in this arm will receive Bioflx crowns after pulp therapy of primary molars. Crown placement will follow the study protocol, and outcomes including vertical dimension, mean biting force, and parental satisfaction will be assessed during follow-up. |
|
| Stainless Steel Crown Group | Active Comparator | Participants in this arm will receive stainless steel crowns after pulp therapy of primary molars. Crown placement will follow the study protocol, and outcomes including vertical dimension, mean biting force, and parental satisfaction will be assessed during follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioflx Crown | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Vertical dimension alterations | 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. | Baseline, immediately after crown placement, 1 week, and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Biting Force Distribution | 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. | Baseline, immediately after crown placement, 1 week, and 4 weeks |
Not provided
Inclusion Criteria:
Pulp-treated primary molars (pulpotomy)
Exclusion Criteria:
Medically compromised or uncooperative children
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman A Hassan, BDS | Contact | 0122931023 | eman.hassan@dentistry.cu.edu.eg | |
| Osama A El Shahawy, PHD | Contact | 01005634755 | osama.shahawy@dentistry.cuedu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Osama A El shahawy, PHD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Giza/Egypt | 12613 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38406007 | Background | Almajed OS. Shaping Smiles: A Narrative Review of Crown Advancements in Pediatric Dentistry. Cureus. 2024 Jan 26;16(1):e52997. doi: 10.7759/cureus.52997. eCollection 2024 Jan. | |
| 32509626 | Background | Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar. |
Not provided
Not provided
Individual participant data will not be shared. The study involves a small sample of pediatric participants, and data confidentiality and participant privacy will be protected according to institutional and ethical requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Participants and the operator are not blinded because of differences between the crown materials and their preparation. The statistician will be blinded.
Not provided
| Stainless Steel Crown | Device | 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 |
|
| Parental Satisfaction With Treatment Impact | 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. | 4 weeks |
| 38911945 | Background | Rahate I, Fulzele P, Thosar N. Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients. F1000Res. 2023 Dec 21;12:756. doi: 10.12688/f1000research.133464.2. eCollection 2023. |
| 37635466 | Background | Maheshkumar K, Chowdhary N, Chowdharry R, Vundela RR, Sonnahalli NK, Anuraaga AT. Bite force evaluation at maximal intercuspal position: An in vivo comparative study between stainless steel and zirconia crowns on primary molar teeth. J Indian Soc Pedod Prev Dent. 2023 Apr-Jun;41(2):89-97. doi: 10.4103/jisppd.jisppd_156_23. |
| 32248585 | Background | Nair K, Chikkanarasaiah N, Poovani S, Thumati P. Digital occlusal analysis of vertical dimension and maximum intercuspal position after placement of stainless steel crown using hall technique in children. Int J Paediatr Dent. 2020 Nov;30(6):805-815. doi: 10.1111/ipd.12647. Epub 2020 May 7. |