Dental Restorations in ChildrenNCT07902570
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
A study testing Preformed 3D-Printed Resin Crown and Bioflx Crown in people with Dental Restorations in Children and Pediatric Dentistry, run by Faculty of Dental Medicine for Girls.
Trial summary
This randomized comparative clinical trial will evaluate and compare the clinical performance of preformed three-dimensional (3D)-printed resin crowns and Bioflx crowns in children with pulp-treated primary molars requiring full coronal restoration. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restorations in Children, Pediatric Dentistry
- What is being tested?
- Preformed 3D-Printed Resin Crown and Bioflx Crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Mar 2028
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both sexes aged 3-9 years. Systemically healthy children. Children with at least two comparable contralateral primary molars requiring pulp therapy and full coronal coverage.
- Children with a Frankl behavior rating of definitely positive or positive.
Who cannot join
- Children with disabilities or systemic diseases. Primary molars with pathological discrepancies in root resorption. Primary molars with furcation inflammation. Children with oral parafunctional habits. Primary molars with root caries. Children with temporomandibular joint disorders. Primary molars expected to undergo physiological exfoliation within 24 months. Children with a Frankl behavior rating of negative or definitely negative.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Somaya Kahwa contact
About this study
Official title: Clinical Performance of Preformed 3D-Printed Resin Crowns Versus Bioflx Crowns Following Pulp Therapy of Primary Molars
This randomized comparative clinical trial will evaluate and compare the clinical performance of preformed three-dimensional (3D)-printed resin crowns and Bioflx crowns in children with pulp-treated primary molars requiring full coronal restoration. The study will use a split-mouth design in which eligible children have two comparable contralateral primary molars treated with the two crown types, with the crown allocation to the right or left tooth determined by a computer-generated random sequence. Crown survival will be the primary outcome. Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after treatment.
Read the detailed description
This randomized comparative clinical trial will evaluate the clinical performance of preformed three-dimensional (3D)-printed resin crowns compared with Bioflx crowns for the restoration of pulp-treated primary molars in children.
The study will use a randomized split-mouth design. Eligible children aged 3-9 years who require pulp therapy and full coronal restoration of at least two comparable contralateral primary molars will receive both crown types. One molar will be restored with a preformed 3D-printed resin crown, and the contralateral molar will be restored with a Bioflx crown. The allocation of crown type to the right or left side will be determined using a computer-generated random sequence.
The primary outcome will be crown survival at 12 months, defined as the crown remaining present and functional without requiring replacement. Crown loss or replacement will be considered treatment failure.
Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after crown placement.
The study will be conducted at the outpatient pediatric dentistry clinic of the Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt. The anticipated enrollment is 18 children, contributing 36 primary molars in total.
- Being tested
- Preformed 3D-Printed Resin Crown, Bioflx Crown
- Keywords
- 3D-printed resin crowns, Bioflx crowns, Primary molars, Pulp therapy, Crown survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preformed 3D-Printed Resin CrownDevice
Preformed three-dimensional (3D)-printed resin crowns will be used for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. The clinical performance of these crowns will be evaluated in a randomized split-mouth design, with each participant receiving a 3D-printed resin crown on one primary molar and a Bioflx crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
Bioflx CrownDevice
Bioflx crowns will be used as the comparison intervention for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. In this randomized split-mouth study, each participant will receive a Bioflx crown on one primary molar and a preformed 3D-printed resin crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Preformed 3D-Printed Resin Crown | Experimental | Preformed 3D-printed resin crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on one of two comparable contralateral primary molars. The side receiving this crown will be determined by a computer-generated random sequence. Receives: Device: Preformed 3D-Printed Resin Crown |
| Bioflx Crown | Active comparator | Bioflx crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on the contralateral primary molar. The side receiving this crown will be determined by a computer-generated random sequence. Receives: Device: Bioflx Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown Survival
Crown survival will be evaluated based on whether the crown remains present and functional without requiring replacement. A crown will be considered a failure if it is lost or requires replacement. Survival will be compared between preformed 3D-printed resin crowns and Bioflx crowns.
Measured: 12 months after crown placement
Secondary outcomes (3)
Modified Plaque Index
Oral plaque accumulation around the crowns will be assessed using the modified plaque index specified in the study protocol. Scores will be compared between the two crown types.
Measured: 1 week and 3, 6, and 12 months after crown placement
Modified Gingival Index
Gingival health around the restored primary molars will be evaluated using the modified gingival index specified in the study protocol. Scores will be compared between the two crown types.
Measured: 1 week and 3, 6, and 12 months after crown placement
Occlusal Wear
Occlusal wear of the crowns will be evaluated clinically according to the assessment method specified in the study protocol. Findings will be compared between preformed 3D-printed resin crowns and Bioflx crowns.
Measured: 3, 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 posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restorations in ChildrenStudies 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
- This study uses a randomized split-mouth design. Each eligible child will receive both interventions on two comparable contralateral primary molars requiring pulp therapy and full coronal coverage. One molar will be restored with a preformed 3D-printed resin crown, and the other with a Bioflx crown. A computer-generated random sequence will determine which crown type is placed on the right or left molar. Clinical outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Somaya Mohsen Anwar, Faculty of Dental Medicine for Girls
- Investigators
- Somaya MA Kahwa, Doctor, Principal investigator, Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902570
- Sponsor's protocol ID
- P-PE-26-02
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Preformed 3D-Printed Resin Crowns Versus Bioflx Crowns Following Pulp Therapy of Primary Molars
- ClinicalTrials.gov ID
- NCT07902570
- Acronym / sponsor ID
- P-PE-26-02
- Keywords
- 3D-printed resin crowns, Bioflx crowns, Primary molars, Pulp therapy, Crown survival
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 29 Oct 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 randomized comparative clinical trial will evaluate and compare the clinical performance of preformed three-dimensional (3D)-printed resin crowns and Bioflx crowns in children with pulp-treated primary molars requiring full coronal restoration. The study will use a split-mouth design in which eligible children have two comparable contralateral primary molars treated with the two crown types, with the crown allocation to the right or left tooth determined by a computer-generated random sequence. Crown survival will be the primary outcome. Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after treatment.
Detailed description
This randomized comparative clinical trial will evaluate the clinical performance of preformed three-dimensional (3D)-printed resin crowns compared with Bioflx crowns for the restoration of pulp-treated primary molars in children.
The study will use a randomized split-mouth design. Eligible children aged 3-9 years who require pulp therapy and full coronal restoration of at least two comparable contralateral primary molars will receive both crown types. One molar will be restored with a preformed 3D-printed resin crown, and the contralateral molar will be restored with a Bioflx crown. The allocation of crown type to the right or left side will be determined using a computer-generated random sequence.
The primary outcome will be crown survival at 12 months, defined as the crown remaining present and functional without requiring replacement. Crown loss or replacement will be considered treatment failure.
Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after crown placement.
The study will be conducted at the outpatient pediatric dentistry clinic of the Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt. The anticipated enrollment is 18 children, contributing 36 primary molars in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized split-mouth design. Each eligible child will receive both interventions on two comparable contralateral primary molars requiring pulp therapy and full coronal coverage. One molar will be restored with a preformed 3D-printed resin crown, and the other with a Bioflx crown. A computer-generated random sequence will determine which crown type is placed on the right or left molar. Clinical outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment.
| Arm | Type | Receives |
|---|---|---|
| Preformed 3D-Printed Resin Crown | Experimental | Device: Preformed 3D-Printed Resin CrownPreformed 3D-printed resin crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on one of two comparable contralateral primary molars. The side receiving this crown will be determined by a computer-generated random sequence. |
| Bioflx Crown | Active comparator | Device: Bioflx CrownBioflx crowns will be used to restore pulp-treated primary molars requiring full coronal coverage. In this randomized split-mouth study, each participant will receive this crown on the contralateral primary molar. The side receiving this crown will be determined by a computer-generated random sequence. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of both sexes aged 3-9 years. Systemically healthy children. Children with at least two comparable contralateral primary molars requiring pulp therapy and full coronal coverage.
- Children with a Frankl behavior rating of definitely positive or positive.
Key exclusion criteria (1 listed)
- Children with disabilities or systemic diseases. Primary molars with pathological discrepancies in root resorption. Primary molars with furcation inflammation. Children with oral parafunctional habits. Primary molars with root caries. Children with temporomandibular joint disorders. Primary molars expected to undergo physiological exfoliation within 24 months. Children with a Frankl behavior rating of negative or definitely negative.
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 |
|---|---|---|
| Preformed 3D-Printed Resin CrownPreformed three-dimensional (3D)-printed resin crowns will be used for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. The clinical performance of these crowns will be evaluated in a randomized split-mouth design, with each participant receiving a 3D-printed resin crown on one primary molar and a Bioflx crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment. | Device | Preformed 3D-Printed Resin Crown |
| Bioflx CrownBioflx crowns will be used as the comparison intervention for full coronal restoration of pulp-treated primary molars in children aged 3-9 years. In this randomized split-mouth study, each participant will receive a Bioflx crown on one primary molar and a preformed 3D-printed resin crown on the contralateral molar. Outcomes will be assessed at 1 week and 3, 6, and 12 months after treatment. | Device | Bioflx Crown |
Primary outcome
Crown Survival
Time frame: 12 months after crown placement
Crown survival will be evaluated based on whether the crown remains present and functional without requiring replacement. A crown will be considered a failure if it is lost or requires replacement. Survival will be compared between preformed 3D-printed resin crowns and Bioflx crowns.
3 secondary outcomes
Modified Plaque Index
Time frame: 1 week and 3, 6, and 12 months after crown placement
Modified Gingival Index
Time frame: 1 week and 3, 6, and 12 months after crown placement
Occlusal Wear
Time frame: 3, 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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Restorations in Children
Active, not recruiting
Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary Molars
Primary Molar Restoration, Dental Restorations in Children
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.
Somaya Kahwa contact
Somaya MA Kahwa, Doctor principal investigator
Faculty of Dental Medicine for Girls, Al-Azhar University, Cairo, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Preformed 3D-Printed Resin Crown and Bioflx Crown in people with Dental Restorations in Children and Pediatric Dentistry, run by Faculty of Dental Medicine for Girls.
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 2 inclusion and 1 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 29 Oct 2026. 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 Somaya MA Kahwa, Doctor (00222638357, somayakahwa.p5821@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crown Survival (time frame: 12 months after crown placement). 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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.