Restoration of Primary Molars with Bioflex CrownsNCT06721741
Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique
A study testing Nusmile bioflex crowns and Stainless steel crowns in people with Restoration of Primary Molars with Bioflex Crowns, run by Cairo University.
Trial summary
This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Restoration of Primary Molars with Bioflex Crowns
- What is being tested?
- Nusmile bioflex crowns and Stainless steel crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Oct 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical Criteria:
- Children from age 4-7.
- Cooperative children and willing for follow-up visits.
- Mandibular second Primary molars with multi-surface caries
- Radiographic criteria:
- Mandibular second Primary molars with at least two-thirds of the root remaining.
Who cannot join
- • General Criteria:
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- •Unable to attend follow-up visits
- •Refuse to participate in the study
- •Uncooperative child
- Clinical Criteria:
Show all 12Show fewer
- • Tooth with grade II or grade III mobility
- •Children with bruxism
- • Pulpally involved teeth
- Radiographic Criteria:
- •Tooth with pathological root resorption
- •Teeth with root caries
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Manal Ahmed Elsayed contact
About this study
Official title: Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique:A Randomized Clinical Study
This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.
Read the detailed description
Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable
- Being tested
- Nusmile bioflex crowns, Stainless steel crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nusmile bioflex crownsOther
The Bioflex crown is a new synthetic crown that has been introduced in pediatric practice. This crown is believed to offer better adaptation, durability, and ease of handling, along with improved aesthetic properties when compared to conventional crowns
Stainless steel crownsOther
Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback
| Study group | Role | What they receive |
|---|---|---|
| Stainless steel crown | Active comparator | Control group Receives: Other: Stainless steel crowns |
| Bioflex crown | Experimental | Intervention group Receives: Other: Nusmile bioflex crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient relevant criteria
- Clinically Success if: No clinical signs or symptoms like:
- Pain
- Dental Abscess/Swelling
- Sinus Tract/ Fistula
- Mobility
- Radiographically Success if:
No pathology visible on x-ray like:
- Internal/External Root Resorption
- Peri-radicular Radiolucency
- Furcation Involvement
- Periapical Pathosis
Measured: 1 Year
Secondary outcomes (1)
Crown Relevant Criteria
- wear of the opposing Binary (yes or no)
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Primary Molars with Bioflex CrownsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hajer ahmed mousa mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721741
- Sponsor's protocol ID
- Bioflex crowns
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2024
- Last updated
- 17 Feb 2025
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique:A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06721741
- Acronym / sponsor ID
- Bioflex crowns
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Dec 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.
This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.
Detailed description
Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stainless steel crown | Active comparator | Other: Stainless steel crownsControl group |
| Bioflex crown | Experimental | Other: Nusmile bioflex crownsIntervention group |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Clinical Criteria:
- Radiographic criteria:
Key exclusion criteria (12 listed)
- <!-- -->
- Clinical Criteria:
- Radiographic Criteria:
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 |
|---|---|---|
| Nusmile bioflex crownsThe Bioflex crown is a new synthetic crown that has been introduced in pediatric practice. This crown is believed to offer better adaptation, durability, and ease of handling, along with improved aesthetic properties when compared to conventional crowns | Other | Bioflex crown |
| Stainless steel crownsPreformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback | Other | Stainless steel crown |
Primary outcome
Patient relevant criteria
Time frame: 1 Year
1. Clinically Success if: No clinical signs or symptoms like: * Pain * Dental Abscess/Swelling * Sinus Tract/ Fistula * Mobility 2. Radiographically Success if: No pathology visible on x-ray like: * Internal/External Root Resorption * Peri-radicular Radiolucency * Furcation Involvement * Periapical Pathosis
1 secondary outcome
Crown Relevant Criteria
Time frame: 1Year
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 17 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Restoration of Primary Molars with Bioflex Crowns
RecruitingObservational study
The Relation Between Oral Hygiene and Microbial Load in the Oral Cavity After Restoring Primary Molars With Two Types of Ready-made Crowns
Carious Lesion, Ready-made Crowns
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.
Manal Ahmed Elsayed contact
Questions about this trial
What is this clinical trial studying?
A study testing Nusmile bioflex crowns and Stainless steel crowns in people with Restoration of Primary Molars with Bioflex Crowns, run by Cairo University.
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 12 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 17 Feb 2025. 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 Hajer Ahmed Mousa (01551106855, hajermousa9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient relevant criteria (time frame: 1 Year). 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 17 Feb 2025.