Success RateNCT06973616
A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars
A study testing Zirconia crown and Bioflx crown in people with Success Rate, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Currently, prefabricated zirconia crowns have been used as an aesthetic restorative material for primary teeth for a few years. Another recently introduced esthetic crown is the Bioflx™ crown. It is made of a resin polymer and claimed to have high strength , flexibility and durability. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Success Rate
- What is being tested?
- Zirconia crown and Bioflx crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteJordan
- Study dates
- 2 Jan 2024to 30 Dec 2026
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 4-10 years
- Healthy child
- Child is cooperative
- Subject has a minimum of two bilateral carious upper or lower primary molars
- Teeth exhibiting carious lesions clinically and radiographically
- Teeth selected should be fully erupted, with no evidence of tooth fracture, and could be isolated adequately for crown cementation
Who cannot join
- Tooth close to exfoliation
- Medical problems in sbjects
- Children requiring advanced behaviour management
- Those not available for future recalls/ follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
Currently, prefabricated zirconia crowns have been used as an aesthetic restorative material for primary teeth for a few years. Another recently introduced esthetic crown is the Bioflx™ crown. It is made of a resin polymer and claimed to have high strength , flexibility and durability. The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
Read the detailed description
Background: Little is known about aesthetic management of decayed primary posterior teeth in children which often requires full-coverage restorations.
Aim: The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
Methods: this study design is a split mouth randomized controlled clinical trial including children ages between 4-10 years old. Each patient will receive a zirconia crown and Bioflx™ crown on either side of the maxillary or mandibular arch. Clinical procedure: The patients will be randomly allocated to receive either crown on the first visit, and the other type on the next visit which will be 1-2 weeks after. Children and teeth meeting the inclusion criteria will be included. Crowns will be prepared under local anesthesia and rubber dam isolation. Crowns will be evaluated at 1, 6, 12 and 24-month recall appointments according to pre-set success and failure criteria.
- Conditions
- Success Rate
- Being tested
- Zirconia crown, Bioflx crown
- Keywords
- Randomized clinical trial, Esthetic crowns, Zirconia crown, Bioflx crown, Primary molars, Deciduous molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crownProcedure or surgery
Also called Esthetic crown
A zirconia esthetic crown will be randomly placed on one side of the jaw
Bioflx crownProcedure or surgery
Also called Esthetic crown
A Bioflx esthetic crown will be randomly placed on one side of the jaw
| Study group | Role | What they receive |
|---|---|---|
| Zirconia esthetic crowns | Active comparator | Zirconia esthetic crowns Receives: Procedure: Zirconia crown |
| Bioflx esthetic crowns | Active comparator | Bioflx esthetic crowns Receives: Procedure: Bioflx crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically susccessful
Normal gingiva (no inflammation or edema) Normal occlusion (not high in occlusion) Parent satisfied (as reported) Child satisfied (as reported)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start2 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Success RateStudies 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
- Model description
- A split mouth randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- OLA Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973616
- Sponsor's protocol ID
- 466-2023
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.
PubMed 27306242Donly KJ, Sasa I, Contreras CI, Mendez MJC. Prospective Randomized Clinical Trial of Primary Molar Crowns: 24-Month Results. Pediatr Dent. 2018 Jul 15;40(4):253-258.
PubMed 30345963Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.
PubMed 25631720Aiem E, Smail-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17.
PubMed 27532506
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
- ClinicalTrials.gov ID
- NCT06973616
- Acronym / sponsor ID
- 466-2023
- Conditions
- Success Rate
- Keywords
- Randomized clinical trial, Esthetic crowns, Zirconia crown, Bioflx crown, Primary molars, Deciduous molars
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 May 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.
Currently, prefabricated zirconia crowns have been used as an aesthetic restorative material for primary teeth for a few years. Another recently introduced esthetic crown is the Bioflx™ crown. It is made of a resin polymer and claimed to have high strength , flexibility and durability. The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
Detailed description
Background: Little is known about aesthetic management of decayed primary posterior teeth in children which often requires full-coverage restorations.
Aim: The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.
Methods: this study design is a split mouth randomized controlled clinical trial including children ages between 4-10 years old. Each patient will receive a zirconia crown and Bioflx™ crown on either side of the maxillary or mandibular arch. Clinical procedure: The patients will be randomly allocated to receive either crown on the first visit, and the other type on the next visit which will be 1-2 weeks after. Children and teeth meeting the inclusion criteria will be included. Crowns will be prepared under local anesthesia and rubber dam isolation. Crowns will be evaluated at 1, 6, 12 and 24-month recall appointments according to pre-set success and failure criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A split mouth randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Zirconia esthetic crowns | Active comparator | Procedure: Zirconia crownZirconia esthetic crowns |
| Bioflx esthetic crowns | Active comparator | Procedure: Bioflx crownBioflx esthetic crowns |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ages 4-10 years
- Healthy child
- Child is cooperative
- Subject has a minimum of two bilateral carious upper or lower primary molars
- Teeth exhibiting carious lesions clinically and radiographically
Key exclusion criteria (4 listed)
- Tooth close to exfoliation
- Medical problems in sbjects
- Children requiring advanced behaviour management
- Those not available for future recalls/ follow up
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 |
|---|---|---|
| Zirconia crownAlso: Esthetic crownA zirconia esthetic crown will be randomly placed on one side of the jaw | Procedure or surgery | Zirconia esthetic crowns |
| Bioflx crownAlso: Esthetic crownA Bioflx esthetic crown will be randomly placed on one side of the jaw | Procedure or surgery | Bioflx esthetic crowns |
Primary outcome
Clinically susccessful
Time frame: 24 months
Normal gingiva (no inflammation or edema) Normal occlusion (not high in occlusion) Parent satisfied (as reported) Child satisfied (as reported)
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 15 May 2025.
- Results publication: PubMed 27306242Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.
- Results publication: PubMed 30345963Donly KJ, Sasa I, Contreras CI, Mendez MJC. Prospective Randomized Clinical Trial of Primary Molar Crowns: 24-Month Results. Pediatr Dent. 2018 Jul 15;40(4):253-258.
- Results publication: PubMed 25631720Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.
- Results publication: PubMed 27532506Aiem E, Smail-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17.
- Individual participant dataSharing planned: No
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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.
OLA Al-Batayneh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crown and Bioflx crown in people with Success Rate, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 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: enrolling by invitation, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically susccessful (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06973616, which also lists 4 linked publications.
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 15 May 2025.