An interventional study of BioFlx crown and Zirconia crown in Clincal Evaluation of BioFlx Vs. Zirconia Crowns, sponsored by Riyadh Elm University. Not yet recruiting. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Riyadh Elm University · Not applicable, Interventional, and Treatment
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:
Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
one NuSmile® BioFlx crown will be placed on primary lower second molar.
Other: BioFlx crown
one zirconia crown will be placed on the contralateral primary lower second molar.
Other: Zirconia crown
NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.
Crown retention
Evaluate whether the crown is present or absent 0= present 1= absent
Time frame: 3, 6, 12 months
Modified gingival index
0= normal 1. mild inflammation 2. moderate inflammation 3. sever inflammation
Time frame: 3, 6, 12 months
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
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
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
Stain resistance
0= no staining 1. minor staining that can be polished 2. noticeable staining that cannot be polished
Time frame: 3, 6, 12 months
Wear of opposing tooth
0= no wear 1. mild wear 2. severe wear
Time frame: 3, 6, 12 months
Color match
0= no color mismatch 1. acceptable crown with color mismatch 2. unacceptable crown with color mismatch
Time frame: 3, 6, 12 months
Anatomic form
0= clinically ideal 1. clinically acceptable (slightly under/over contoured) 2. clinically unacceptable (crown is missing or causing pain)
Time frame: 3, 6, 12 months
Marginal integrity and discoloration
0= clinically ideal 1. clinically acceptable with slight discoloration 2. clinically unacceptable with clear discoloration
Time frame: 3, 6, 12 months
Proximal contact
0= clinically ideal with acceptable resistance to the passage of floss 1. clinically acceptable with tight or loose passage of floss 2. clinically unacceptable with no contact with adjacent tooth
Time frame: 3, 6, 12 months
Recurrent caries
0= clinically ideal with no presence of recurrent caries 1= clinically unacceptable with evidence of recurrent caries
Time frame: 3, 6, 12 months
No study locations are listed for this record.
Start is estimated for May 2025; primary completion for Nov 2025, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Riyadh Elm University