Clincal Evaluation of BioFlx Vs. Zirconia CrownsNCT06895707
Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars
A study testing BioFlx crown and Zirconia crown in people with Clincal Evaluation of BioFlx Vs. Zirconia Crowns, run by Riyadh Elm University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Clincal Evaluation of BioFlx Vs. Zirconia Crowns
- What is being tested?
- BioFlx crown and Zirconia crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 9Show fewer
- Primary lower second molars that can be adequately isolated.
- Pulptomized primary lower second molars.
- Primary lower second molars with multi-surface caries.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical 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:
Read more
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.
- Being tested
- BioFlx crown, Zirconia crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioFlx crownOther
NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
Zirconia crownOther
Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.
| Study group | Role | What they receive |
|---|---|---|
| Primary lower second molar | Experimental | one NuSmile® BioFlx crown will be placed on primary lower second molar. Receives: Other: BioFlx crown |
| Contralateral primary lower second molar | Active comparator | one zirconia crown will be placed on the contralateral primary lower second molar. Receives: Other: Zirconia crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown retention
Evaluate whether the crown is present or absent 0= present
1= absent
Measured: 3, 6, 12 months
Secondary outcomes (11)
Modified gingival index
0= normal
- mild inflammation
- moderate inflammation
- sever inflammation
Measured: 3, 6, 12 months
Plaque index
Plaque index 0= no plaque
- film at gingival margin
- moderate accumulation
- abundance of plaque
Measured: 3, 6, 12 months
Occlusion
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
Measured: 3, 6, 12 months
Surface roughness
0= clinically ideal with smooth crown surface
- clinically acceptable with slight rough surface
- clinically unacceptable with crown fracture or pitting that require replacement
Measured: 3, 6, 12 months
Stain resistance
0= no staining
- minor staining that can be polished
- noticeable staining that cannot be polished
Measured: 3, 6, 12 months
Wear of opposing tooth
0= no wear
- mild wear
- severe wear
Measured: 3, 6, 12 months
Color match
0= no color mismatch
- acceptable crown with color mismatch
- unacceptable crown with color mismatch
Measured: 3, 6, 12 months
Anatomic form
0= clinically ideal
- clinically acceptable (slightly under/over contoured)
- clinically unacceptable (crown is missing or causing pain)
Measured: 3, 6, 12 months
Marginal integrity and discoloration
0= clinically ideal
- clinically acceptable with slight discoloration
- clinically unacceptable with clear discoloration
Measured: 3, 6, 12 months
Proximal contact
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
Measured: 3, 6, 12 months
Recurrent caries
0= clinically ideal with no presence of recurrent caries
1= clinically unacceptable with evidence of recurrent caries
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clincal Evaluation of BioFlx Vs. Zirconia CrownsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatimah alsuwaiyan, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895707
- Sponsor's protocol ID
- FPGRP/2024/822/1146/1065
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06895707
- Acronym / sponsor ID
- FPGRP/2024/822/1146/1065
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary lower second molar | Experimental | Other: BioFlx crownone NuSmile® BioFlx crown will be placed on primary lower second molar. |
| Contralateral primary lower second molar | Active comparator | Other: Zirconia crownone zirconia crown will be placed on the contralateral primary lower second molar. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioFlx crownNuSmile® BioFlx crown (Group A) will be placed on primary lower second molar. | Other | Primary lower second molar |
| Zirconia crownZirconia crown (Group B) will be placed on the contralateral primary lower second molar. | Other | Contralateral primary lower second molar |
Primary outcome
Crown retention
Time frame: 3, 6, 12 months
Evaluate whether the crown is present or absent 0= present 1= absent
11 secondary outcomes
Modified gingival index
Time frame: 3, 6, 12 months
Plaque index
Time frame: 3, 6, 12 months
Occlusion
Time frame: 3, 6, 12 months
Surface roughness
Time frame: 3, 6, 12 months
Stain resistance
Time frame: 3, 6, 12 months
Wear of opposing tooth
Time frame: 3, 6, 12 months
Color match
Time frame: 3, 6, 12 months
Anatomic form
Time frame: 3, 6, 12 months
Marginal integrity and discoloration
Time frame: 3, 6, 12 months
Proximal contact
Time frame: 3, 6, 12 months
Recurrent caries
Time frame: 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing BioFlx crown and Zirconia crown in people with Clincal Evaluation of BioFlx Vs. Zirconia Crowns, run by Riyadh Elm University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatimah A Alsuwaiyan, BDS (001966508322281, fatimah.a.alsuwaiyan2022@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crown retention (time frame: 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.