CariesNCT06677983
Clinical Performance and Acceptance of Bioflx Crowns
A study testing Bioflex Crowns and Stainless steel crown in people with Caries, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Caries
- What is being tested?
- Bioflex Crowns and Stainless steel crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Jul 2025
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A child with primary molars is indicated for full coverage.
Who cannot join
- Children with any systemic disease
- Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
- Children cooperation (1,2) according to Frankl scale
- Parents are unwilling to enroll their children in study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
Alexandria
Pharos univeristy, 3877700
Rabab K ElGhandour, PhD
About this study
Official title: Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.
- Conditions
- Caries
- Being tested
- Bioflex Crowns, Stainless steel crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioflex CrownsOther
A preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area.
Stainless steel crownOther
An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified.
| Study group | Role | What they receive |
|---|---|---|
| Bioflex | Experimental | Not described Receives: Other: Bioflex Crowns |
| SSC | Active comparator | Not described Receives: Other: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical success
The crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.
Measured: baseline, 6 months, and 12 months
parental satisfaction
The questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain.
Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Feb 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677983
- Sponsor's protocol ID
- 02202409293266
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06677983
- Acronym / sponsor ID
- 02202409293266
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioflex | Experimental | Other: Bioflex Crowns |
| SSC | Active comparator | Other: Stainless steel crown |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A child with primary molars is indicated for full coverage.
Key exclusion criteria (4 listed)
- Children with any systemic disease
- Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
- Children cooperation (1,2) according to Frankl scale
- Parents are unwilling to enroll their children in study
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 |
|---|---|---|
| Bioflex CrownsA preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area. | Other | Bioflex |
| Stainless steel crownAn appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified. | Other | SSC |
Primary outcome
Change in clinical success
Time frame: baseline, 6 months, and 12 months
The crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.
parental satisfaction
Time frame: through study completion, an average of 6 months
The questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain. Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).
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 7 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioflex Crowns and Stainless steel crown in people with Caries, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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 1 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: looking for participants now, as of the sponsor's last update on 7 Nov 2024. 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 Egypt. 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?
Contact Rabab K ElGhandour, PhD (01222469150, rabab.elghandour@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical success (time frame: baseline, 6 months, and 12 months). The study lists 2 primary outcomes in all. 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 7 Nov 2024.