Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars

Официальное название

Vertical Dimension Changes and Mean Biting Force Following Bioflx Placement Over Pulp-treated Primary Molars Versus Stainless Steel Crowns: A Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Bioflx 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.
• Устройство Stainless 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

Первичные конечные точки

• Vertical dimension alterations [Срок оценки: Baseline, immediately after crown placement, 1 week, and 4 weeks]

Вторичные конечные точки (2)

• Mean Biting Force Distribution [Срок оценки: Baseline, immediately after crown placement, 1 week, and 4 weeks]
• Parental Satisfaction With Treatment Impact [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Публикации

• 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. PMID 38406007
• 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. PMID 32509626
• 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. PMID 38911945
• 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. PMID 37635466
• 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. PMID 32248585

Идентификаторы

NCT: NCT07523776 · CU-PD-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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