Dental CariesNCT07471360
Clinical Performance and Immediate Child and Parental Satis-faction With BioFlx Crowns in Primary Molars: A Prospective, Single-Arm, Non-Randomized Interventional Study
A study testing Bioflx pediatric dental posterior crowns in people with Dental Caries, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Bioflx pediatric dental posterior crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children or with mild stable systemic medical condition such as controlled asthma, Age 6 to 9 years
- Cooperative
- One primary molar that requires a full-coverage restoration with at least one proximal contact with the adjacent tooth
- No clinical or radiographic signs or symptoms of periradicular pathology
- Normal interproximal bone levels
- No more than one-third root resorption radiographically
Who cannot join
- Children with severe malocclusion
- Children with periodontal disease
- Children requiring comprehensive dental treatment under general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. Healthy children or children with mild, stable systemic medical conditions, who were cooperative and required at least one full-coverage restoration in a primary molar were recruited from the pe-diatric dentistry clinics at King Abdulaziz University Faculty of Dentistry. BioFlx crowns were placed by trained pediatric dentistry residents under a consultant's supervision. Immediately after crown cementation, proximal contact and occlusion were recorded. At three- and six-month fol-low-up visits, clinical outcomes evaluated were the proximal contacts, occlusion, crown retention, staining, wear of the opposing tooth, marginal integrity, and any changes in the crown material surface. In addition, plaque accumulation and gingival health around each crowned tooth were assessed at the tooth level. Immediate post-treatment satisfaction of children and their parents was assessed following crown cementation.
- Conditions
- Dental Caries
- Being tested
- Bioflx pediatric dental posterior crowns
- Keywords
- pediatric dentistry, satisfaction, primary molars, BioFlx, full-coverage restoration
- Medical subject headings
- Dental Caries, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioflx pediatric dental posterior crownsOther
Bioflx pediatric dental posterior crowns
| Study group | Role | What they receive |
|---|---|---|
| BioFlx crowns | Experimental | BioFlx crowns Receives: Other: Bioflx pediatric dental posterior crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Before preparation, participant-level baseline data were recorded, including dental history and a comprehensive preoperative full-mouth oral health assessment comprising dental caries experience recorded using the dmft/DMFT indices, oral hygiene using the Greene and Vermillion Simplified Oral Hygiene Index (OHI-S), and gingival health assessed using the Löe and Silness Gingival Index.
Furthermore, the clinical assessment comprised multiple parameters, including selected criteria adapted from the modified United States Public Health Service (USPHS) system for the direct clinical evaluation of restorations [16], namely marginal integrity and crown staining; crown-specific clinical criteria adapted from Donly et al., namely proximal contact, occlusion, crown retention, and wear of the opposing tooth; established plaque accumulation and bleeding on probing and a study-specific criterion for evaluating the surface integrity of BioFlx crowns.
Measured: 6 months
Secondary outcomes (1)
child and parental satisfaction
Child and parental satisfaction survey.The questionnaire encompass an individual interview with the children and their parents/guardians in a separate setting. The participants were asked to indicate their satisfaction with the crown color, shape, size, and overall appearance on a Likert's scale from one to ten, in which one indicates very satisfied/very acceptable and ten indicates not satisfied at all/ not acceptable at all.
Measured: immediate post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Dec 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahad Abudawood, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471360
- Sponsor's protocol ID
- 53-03-24
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to privacy
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Immediate Child and Parental Satis-faction With BioFlx Crowns in Primary Molars: A Prospective, Single-Arm, Non-Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT07471360
- Acronym / sponsor ID
- 53-03-24
- Conditions
- Dental Caries
- Keywords
- pediatric dentistry, satisfaction, primary molars, BioFlx, full-coverage restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Mar 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.
Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. Healthy children or children with mild, stable systemic medical conditions, who were cooperative and required at least one full-coverage restoration in a primary molar were recruited from the pe-diatric dentistry clinics at King Abdulaziz University Faculty of Dentistry. BioFlx crowns were placed by trained pediatric dentistry residents under a consultant's supervision. Immediately after crown cementation, proximal contact and occlusion were recorded. At three- and six-month fol-low-up visits, clinical outcomes evaluated were the proximal contacts, occlusion, crown retention, staining, wear of the opposing tooth, marginal integrity, and any changes in the crown material surface. In addition, plaque accumulation and gingival health around each crowned tooth were assessed at the tooth level. Immediate post-treatment satisfaction of children and their parents was assessed following crown cementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioFlx crowns | Experimental | Other: Bioflx pediatric dental posterior crownsBioFlx crowns |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children or with mild stable systemic medical condition such as controlled asthma, Age 6 to 9 years
- Cooperative
- One primary molar that requires a full-coverage restoration with at least one proximal contact with the adjacent tooth
- No clinical or radiographic signs or symptoms of periradicular pathology
- Normal interproximal bone levels
Key exclusion criteria (3 listed)
- Children with severe malocclusion
- Children with periodontal disease
- Children requiring comprehensive dental treatment under general anesthesia.
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 pediatric dental posterior crownsBioflx pediatric dental posterior crowns | Other | BioFlx crowns |
Primary outcome
Clinical performance
Time frame: 6 months
Before preparation, participant-level baseline data were recorded, including dental history and a comprehensive preoperative full-mouth oral health assessment comprising dental caries experience recorded using the dmft/DMFT indices, oral hygiene using the Greene and Vermillion Simplified Oral Hygiene Index (OHI-S), and gingival health assessed using the Löe and Silness Gingival Index. Furthermore, the clinical assessment comprised multiple parameters, including selected criteria adapted from the modified United States Public Health Service (USPHS) system for the direct clinical evaluation of restorations [16], namely marginal integrity and crown staining; crown-specific clinical criteria adapted from Donly et al., namely proximal contact, occlusion, crown retention, and wear of the opposing tooth; established plaque accumulation and bleeding on probing and a study-specific criterion for evaluating the surface integrity of BioFlx crowns.
1 secondary outcome
child and parental satisfaction
Time frame: immediate post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Due to privacy
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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 Bioflx pediatric dental posterior crowns in people with Dental Caries, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 3 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: finished, as of the sponsor's last update on 2 Sep 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance (time frame: 6 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 2 Sep 2026.