Dental CariesNCT07691905
Zirconia and Bioflx Crowns for Primary Anterior Teeth
A study testing Zirconia Crown and Bioflx Crown in people with Dental Caries and Tooth Hypomineralization, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This parallel-group randomized controlled trial will compare the clinical performance of prefabricated zirconia and Bioflx crowns for restoring primary maxillary anterior teeth in children aged 3 to 5 years. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Dental Caries, Tooth Hypomineralization
- What is being tested?
- Zirconia Crown and Bioflx Crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- 4 Jan 2026to Apr 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 5 years.
- Children requiring full-coverage restoration of one or more primary maxillary anterior teeth.
- Presence of an opposing tooth.
- Target tooth with at least two carious surfaces, caries involving the incisal edge, or discoloration associated with hypomineralization.
- Written informed consent from a parent or legal guardian and willingness to comply with treatment and follow-up visits.
Who cannot join
- Allergy to Fuji IX Extra glass ionomer cement.
- Acute systemic disease.
- Crowded teeth affecting crown placement.
- Pulp exposure before treatment.
- Inadequate remaining clinical crown structure after tooth preparation.
- Absence of an opposing tooth.
Show all 10Show fewer
- Bruxism or deep bite.
- Tooth close to exfoliation or root resorption exceeding one-half of the root length.
- Caries limited to a single surface without proximal involvement.
- History of trauma affecting the target tooth.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
Huế, 530000
About this study
Official title: Clinical Outcomes of Prefabricated Zirconia and Bioflx Crowns for Restoring Primary Maxillary Anterior Teeth: A Randomized Controlled Trial
This parallel-group randomized controlled trial will compare the clinical performance of prefabricated zirconia and Bioflx crowns for restoring primary maxillary anterior teeth in children aged 3 to 5 years. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a zirconia crown or a Bioflx crown.
Clinical outcomes will be assessed at 3, 6, and 12 months after crown placement. Evaluations will include gingival health, plaque accumulation, wear of the opposing tooth, crown retention, and clinical symptoms of the treated tooth. Parent satisfaction with the esthetic outcome will also be evaluated.
The study aims to provide comparative clinical evidence on the effectiveness of zirconia and Bioflx crowns for restoration of primary maxillary anterior teeth.
Read the detailed description
Primary maxillary anterior teeth are important for esthetics, speech, mastication, and maintenance of normal oral function in young children. Extensive caries and hypomineralization may result in substantial loss of tooth structure and require full-coverage restoration. Prefabricated zirconia and Bioflx crowns are esthetic restorative options; however, comparative clinical evidence for their use in primary maxillary anterior teeth remains limited.
This study is a parallel-group randomized controlled clinical trial conducted in children aged 3 to 5 years who require full-coverage restoration of primary maxillary anterior teeth. Eligible participants must have an opposing tooth and at least two carious surfaces on the target tooth, caries involving the incisal edge, or discoloration associated with hypomineralization. Children with acute systemic disease, allergy to the luting cement, pulp exposure before treatment, inadequate remaining tooth structure, severe bruxism or deep bite, advanced root resorption, previous trauma affecting the target tooth, or other predefined exclusion criteria will not be enrolled.
A minimum of 120 teeth will be included. Randomization will be performed at the participant level using a computer-generated variable block sequence with a 1:1 allocation ratio. Allocation concealment will be maintained using sequentially numbered opaque sealed envelopes.
Participants will receive either prefabricated zirconia crowns or prefabricated Bioflx crowns. Clinical and radiographic examinations will be completed before treatment. Crown preparation and cementation procedures will be standardized, and Fuji IX Extra glass ionomer cement will be used for crown placement.
The primary outcome will be gingival health at 6 months after crown placement. Secondary outcomes will include plaque accumulation, wear of opposing teeth, crown retention, clinical symptoms of crowned teeth, and parent satisfaction with crown esthetics. Follow-up assessments will be performed at 3, 6, and 12 months. Statistical analyses will account for clustering when more than one tooth is included from the same participant.
- Conditions
- Dental Caries, Tooth Hypomineralization
- Being tested
- Zirconia Crown, Bioflx Crown
- Keywords
- Primary Maxillary Anterior Teeth, Zirconia Crowns, Bioflx Crowns
- Medical subject headings
- Dental Caries, Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia CrownOther
Prefabricated zirconia crowns manufactured by Shinhung, Republic of Korea, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol.
Bioflx CrownOther
Prefabricated Bioflx crowns manufactured by Kids-e-Dental, India, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Zirconia | Active comparator | Participants receive prefabricated zirconia crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement. Receives: Other: Zirconia Crown |
| Bioflx | Experimental | Participants receive prefabricated Bioflx crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement. Receives: Other: Bioflx Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival index
Gingival status adjacent to crowned primary maxillary anterior teeth, assessed using the Löe and Silness Gingival Index. Lower scores indicate better gingival health.
Measured: 3, 6, and 12 months after crown placement
Fluorescent Plaque Index
Plaque accumulation on crowned primary maxillary anterior teeth, assessed using QrayScan Plus according to the Fluorescent Plaque Index (FPI; 0-5). Higher scores indicate greater plaque accumulation.
Measured: 3, 6, and 12 months after crown placement
Opposing Tooth Wear
Wear of the tooth opposing the crowned primary maxillary anterior tooth, assessed clinically on a 0-4 ordinal scale. Higher scores indicate greater enamel and dentin loss.
Measured: 3, 6, and 12 months after crown placement
Crown Retention
Retention status of the prefabricated crown, categorized as retained or loose/lost.
Measured: 3, 6, and 12 months after crown placement
Clinical Status of Crowned Teeth
Clinical status of teeth restored with prefabricated crowns, categorized as asymptomatic, sensitive, mobile, painful, or swollen.
Measured: 3, 6, and 12 months after crown placement
Secondary outcomes (1)
Parental Satisfaction
Parental satisfaction with the esthetic outcome of crown restoration, assessed using a 4-point Likert scale for crown shape, color, alignment, interdental spacing, perceived crowding, and other esthetic abnormalities. Lower scores indicate greater satisfaction.
Measured: 6 and 12 months after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start4 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Van Nhat Thang, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691905
- Sponsor's protocol ID
- H2025/387
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gill A, Garcia M, Won An S, Scott J, Seminario AL. Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months. Pediatr Dent. 2020 Sep 15;42(5):367-372.
PubMed 33087221
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Prefabricated Zirconia and Bioflx Crowns for Restoring Primary Maxillary Anterior Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07691905
- Acronym / sponsor ID
- H2025/387
- Conditions
- Dental Caries, Tooth Hypomineralization
- Keywords
- Primary Maxillary Anterior Teeth, Zirconia Crowns, Bioflx Crowns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Jul 2026 (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.
This parallel-group randomized controlled trial will compare the clinical performance of prefabricated zirconia and Bioflx crowns for restoring primary maxillary anterior teeth in children aged 3 to 5 years. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a zirconia crown or a Bioflx crown.
Clinical outcomes will be assessed at 3, 6, and 12 months after crown placement. Evaluations will include gingival health, plaque accumulation, wear of the opposing tooth, crown retention, and clinical symptoms of the treated tooth. Parent satisfaction with the esthetic outcome will also be evaluated.
The study aims to provide comparative clinical evidence on the effectiveness of zirconia and Bioflx crowns for restoration of primary maxillary anterior teeth.
Detailed description
Primary maxillary anterior teeth are important for esthetics, speech, mastication, and maintenance of normal oral function in young children. Extensive caries and hypomineralization may result in substantial loss of tooth structure and require full-coverage restoration. Prefabricated zirconia and Bioflx crowns are esthetic restorative options; however, comparative clinical evidence for their use in primary maxillary anterior teeth remains limited.
This study is a parallel-group randomized controlled clinical trial conducted in children aged 3 to 5 years who require full-coverage restoration of primary maxillary anterior teeth. Eligible participants must have an opposing tooth and at least two carious surfaces on the target tooth, caries involving the incisal edge, or discoloration associated with hypomineralization. Children with acute systemic disease, allergy to the luting cement, pulp exposure before treatment, inadequate remaining tooth structure, severe bruxism or deep bite, advanced root resorption, previous trauma affecting the target tooth, or other predefined exclusion criteria will not be enrolled.
A minimum of 120 teeth will be included. Randomization will be performed at the participant level using a computer-generated variable block sequence with a 1:1 allocation ratio. Allocation concealment will be maintained using sequentially numbered opaque sealed envelopes.
Participants will receive either prefabricated zirconia crowns or prefabricated Bioflx crowns. Clinical and radiographic examinations will be completed before treatment. Crown preparation and cementation procedures will be standardized, and Fuji IX Extra glass ionomer cement will be used for crown placement.
The primary outcome will be gingival health at 6 months after crown placement. Secondary outcomes will include plaque accumulation, wear of opposing teeth, crown retention, clinical symptoms of crowned teeth, and parent satisfaction with crown esthetics. Follow-up assessments will be performed at 3, 6, and 12 months. Statistical analyses will account for clustering when more than one tooth is included from the same participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zirconia | Active comparator | Other: Zirconia CrownParticipants receive prefabricated zirconia crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement. |
| Bioflx | Experimental | Other: Bioflx CrownParticipants receive prefabricated Bioflx crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 5 years.
- Children requiring full-coverage restoration of one or more primary maxillary anterior teeth.
- Presence of an opposing tooth.
- Target tooth with at least two carious surfaces, caries involving the incisal edge, or discoloration associated with hypomineralization.
- Written informed consent from a parent or legal guardian and willingness to comply with treatment and follow-up visits.
Key exclusion criteria (10 listed)
- Allergy to Fuji IX Extra glass ionomer cement.
- Acute systemic disease.
- Crowded teeth affecting crown placement.
- Pulp exposure before treatment.
- Inadequate remaining clinical crown structure after tooth preparation.
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 CrownPrefabricated zirconia crowns manufactured by Shinhung, Republic of Korea, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol. | Other | Zirconia |
| Bioflx CrownPrefabricated Bioflx crowns manufactured by Kids-e-Dental, India, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol. | Other | Bioflx |
Primary outcome
Gingival index
Time frame: 3, 6, and 12 months after crown placement
Gingival status adjacent to crowned primary maxillary anterior teeth, assessed using the Löe and Silness Gingival Index. Lower scores indicate better gingival health.
Fluorescent Plaque Index
Time frame: 3, 6, and 12 months after crown placement
Plaque accumulation on crowned primary maxillary anterior teeth, assessed using QrayScan Plus according to the Fluorescent Plaque Index (FPI; 0-5). Higher scores indicate greater plaque accumulation.
Opposing Tooth Wear
Time frame: 3, 6, and 12 months after crown placement
Wear of the tooth opposing the crowned primary maxillary anterior tooth, assessed clinically on a 0-4 ordinal scale. Higher scores indicate greater enamel and dentin loss.
Crown Retention
Time frame: 3, 6, and 12 months after crown placement
Retention status of the prefabricated crown, categorized as retained or loose/lost.
Clinical Status of Crowned Teeth
Time frame: 3, 6, and 12 months after crown placement
Clinical status of teeth restored with prefabricated crowns, categorized as asymptomatic, sensitive, mobile, painful, or swollen.
1 secondary outcome
Parental Satisfaction
Time frame: 6 and 12 months after crown placement
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 9 Jul 2026.
- Results publication: PubMed 33087221Gill A, Garcia M, Won An S, Scott J, Seminario AL. Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months. Pediatr Dent. 2020 Sep 15;42(5):367-372.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental Caries and Tooth Hypomineralization, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. 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 Vietnam. 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?
Gingival index (time frame: 3, 6, and 12 months after crown placement). The study lists 5 primary outcomes in all. 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 NCT07691905, which also lists 1 linked publication.
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 9 Jul 2026.