Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06677983

Clinical Performance and Acceptance of Bioflx Crowns

Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Caries

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt

Alexandria, Egypt

Location status: Recruiting

Location contact

Pharos univeristy

CONTACT

3877700

Rabab K ElGhandour, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A child with primary molars is indicated for full coverage.

Exclusion criteria

  • Children with any systemic disease
  • Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
  • Children cooperation (1,2) according to Frankl scale
  • Parents are unwilling to enroll their children in study

Treatment and study plan

Bioflex Crowns

Other

A preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area.

Stainless steel crown

Other

An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified.

Primary outcomes

  1. Change in clinical success

    Time frame: baseline, 6 months, and 12 months

    The crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.

  2. parental satisfaction

    Time frame: through study completion, an average of 6 months

    The questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain.

    Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).

Study contacts

Contact information is provided by the study sponsor or research team.

Rabab K ElGhandour, PhD

CONTACT

[email protected]

01222469150

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.