NCT07523776

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Apr 2026Aug 2026

Study Start

First participant enrolled

April 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 6, 2026

Last Update Submit

April 6, 2026

Conditions

Early Childhood CariesDental CariesPulp-Treated Primary Molars

Keywords

Bioflx CrownStainless Steel CrownPulpotomyPediatric DentistryT-Scan

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Mean Biting Force Distribution

    Baseline, immediately after crown placement, 1 week, and 4 weeks

  • Parental Satisfaction With Treatment Impact

    4 weeks

Study Arms (2)

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.

Device: Bioflx Crown

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.

Device: Stainless Steel Crown

Interventions

Stainless Steel CrownDEVICE

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

Stainless Steel Crown Group
Bioflx CrownDEVICE

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.

Bioflx Crown Group

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza/Egypt, 12613, Egypt

Location

Related Publications (5)

  • Almajed OS. Shaping Smiles: A Narrative Review of Crown Advancements in Pediatric Dentistry. Cureus. 2024;16(1):e52997. doi:10.7759/cureus.52997.

    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.

    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.

    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.

    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.

    BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Osama A El shahawy, PHD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman A Hassan, BDS

CONTACT

0122931023eman.hassan@dentistry.cu.edu.eg

Osama A El Shahawy, PHD

CONTACT

01005634755osama.shahawy@dentistry.cuedu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and the operator are not blinded because of differences between the crown materials and their preparation. The statistician will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Candidate, Pediatric Dentistry, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

EG(1)