Clinical trial Recruiting at 1 site Interventional Ages 3 to 5

Bioflx crowns vs. celluloid strip crowns for front baby teeth

Official title: Comparative Clinical Evaluation of Bioflx and Celluloid Strip Crowns in Restoring Primary Anterior Teeth

Run by Tanta University · NCT07883187 · Data updated 2026-11-12

This trial tests whether prefabricated Bioflx crowns perform as well as conventional Celluloid strip crowns for restoring badly decayed or injured front baby teeth in young children.

Quick facts

Study typeInterventional
Ages3 Years to 5 Years
SexAll
Enrollment40 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta)
StatusRecruiting
StartedNovember 9, 2025
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedOctober 22, 2026
Trial IDNCT07883187 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy children aged 3-5 who are cooperative and have bilateral anterior primary teeth with multi-surface caries requiring full coronal restoration and sufficient root structure.

Probably not a fit

Children with non-restorable teeth, single-surface restorations, or poor cooperation may not benefit from this comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized study, 40 children aged 3 to 5 with bilateral front primary teeth needing full coronal restoration receive a Bioflx crown on one tooth and a Celluloid strip crown on the opposite tooth. Outcomes are measured at 3, 6, and 9 months using USPHS criteria for marginal integrity, color match, restoration integrity, and proximal contacts, along with plaque and gingival indices. The aim is to compare clinical performance and durability between the two crown types in a pediatric population. Results will inform choices for restoring primary anterior teeth in young, cooperative children.

Why it matters

Potential benefit: If Bioflx crowns perform at least as well as strip crowns, children may benefit from a faster or more durable restoration option for primary front teeth.

How similar studies have gone: Previous clinical work in similar pediatric crown comparisons has shown variable success; this study provides direct comparative data for Bioflx crowns in primary dentition.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Healthy children aged 3-5 years with cooperative behavior (Frankl's behavior rating scale 3-4).
* Bilateral anterior primary teeth affected by multi-surface caries requiring full coronal restoration.
* At least two-thirds of the root structure is present, and adequate coronal tooth structure to retain the crown.

Exclusion Criteria:

* Non-restorable teeth
* Teeth with single-surface restorations.
* Previous full-coverage restoration or large unsuccessful restoration on the target tooth.
* Children with oral parafunctional habits (e.g., thumb sucking, bruxism).
* Advanced physiologic root resorption (\>1/3).

Where it's running

  • faculty of dentistry, Tanta university
    Tanta, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.