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

ConditionClincal Evaluation of BioFlx Vs. Zirconia Crowns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorRiyadh Elm University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 5-9 years old.

American Society of Anesthesiologists Classification I or II status.

Cooperative child.

Obtained informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BioFlx crown

    Other intervention

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

  • Zirconia crown

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Primary lower second molarExperimental treatment 1 intervention
Group B: Contralateral primary lower second molarActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Crown retention

Evaluate whether the crown is present or absent 0= present 1= absent

Time frame
3, 6, 12 months

Secondary outcomes

1

Modified gingival index

0= normal 1. mild inflammation 2. moderate inflammation 3. sever inflammation

Time frame
3, 6, 12 months
2

Plaque index

Plaque index 0= no plaque 1. film at gingival margin 2. moderate accumulation 3. abundance of plaque

Time frame
3, 6, 12 months
3

Occlusion

0= clinically ideal with crown in harmony with occlusion 1. clinically acceptable with crown occluding slightly high or low 2. clinically unacceptable and crown needs to be replaced

Time frame
3, 6, 12 months
4

Surface roughness

0= clinically ideal with smooth crown surface 1. clinically acceptable with slight rough surface 2. clinically unacceptable with crown fracture or pitting that require replacement

Time frame
3, 6, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riyadh Elm University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: