Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06895707

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars

The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients.

The main questions it aims to answer are:

Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins?

Researchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar.

Participants:

* Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar. * Participants will be recalled and evaluated after 3, 6, and 12 months.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Clincal Evaluation of BioFlx Vs. Zirconia Crowns

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 5-9 years old.
  • American Society of Anesthesiologists Classification I or II status.
  • Cooperative child.
  • Obtained informed consent.
  • Two primary lower second molars requiring full coverage restorations.
  • Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.
  • Primary lower second molars that can be adequately isolated.
  • Pulptomized primary lower second molars.
  • Primary lower second molars with multi-surface caries.

Exclusion criteria

  • American Society of Anesthesiologists Classification higher or equal to three statuses.
  • Informed consent is not obtained.
  • Allergy to local anesthesia.
  • Non-restorable primary lower second molars.

Treatment and study plan

bioflx crown

Other

NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.

zirconia crown

Other

Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.

Primary outcomes

  1. Crown retention

    Time frame: 3, 6, 12 months

    Evaluate whether the crown is present or absent 0= present

    1= absent

Secondary outcomes

  1. Modified gingival index

    Time frame: 3, 6, 12 months

    0= normal

    • mild inflammation
    • moderate inflammation
    • sever inflammation

  2. Plaque index

    Time frame: 3, 6, 12 months

    Plaque index 0= no plaque

    • film at gingival margin
    • moderate accumulation
    • abundance of plaque

  3. Occlusion

    Time frame: 3, 6, 12 months

    0= clinically ideal with crown in harmony with occlusion

    • clinically acceptable with crown occluding slightly high or low
    • clinically unacceptable and crown needs to be replaced

  4. Surface roughness

    Time frame: 3, 6, 12 months

    0= clinically ideal with smooth crown surface

    • clinically acceptable with slight rough surface
    • clinically unacceptable with crown fracture or pitting that require replacement

  5. Stain resistance

    Time frame: 3, 6, 12 months

    0= no staining

    • minor staining that can be polished
    • noticeable staining that cannot be polished

  6. Wear of opposing tooth

    Time frame: 3, 6, 12 months

    0= no wear

    • mild wear
    • severe wear

  7. Color match

    Time frame: 3, 6, 12 months

    0= no color mismatch

    • acceptable crown with color mismatch
    • unacceptable crown with color mismatch

  8. Anatomic form

    Time frame: 3, 6, 12 months

    0= clinically ideal

    • clinically acceptable (slightly under/over contoured)
    • clinically unacceptable (crown is missing or causing pain)

  9. Marginal integrity and discoloration

    Time frame: 3, 6, 12 months

    0= clinically ideal

    • clinically acceptable with slight discoloration
    • clinically unacceptable with clear discoloration

  10. Proximal contact

    Time frame: 3, 6, 12 months

    0= clinically ideal with acceptable resistance to the passage of floss

    • clinically acceptable with tight or loose passage of floss
    • clinically unacceptable with no contact with adjacent tooth

  11. Recurrent caries

    Time frame: 3, 6, 12 months

    0= clinically ideal with no presence of recurrent caries

    1= clinically unacceptable with evidence of recurrent caries

Study contacts

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

Fatimah A Alsuwaiyan, BDS

CONTACT

[email protected]

001966508322281

Sponsors and collaborators

Lead sponsor

Riyadh Elm University

Other

Registry information

Official study title

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Mar 26, 2025
Registry last updated
Mar 30, 2025

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.