Carious Lesionbioflex crownNCT06767670
The Relation Between Oral Hygiene and Microbial Load in the Oral Cavity After Restoring Primary Molars With Two Types of Ready-made Crowns
An observational study of Carious Lesion and Ready-made Crowns, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Carious Lesion, Ready-made Crowns
- What is being tested?
- stainless steel crown and bioflex crown
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Oct 2026to 1 Oct 2027
- Phase
- Observational
- 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
Study population: A total of 10 patients 4-8 years old will be selected according to the established inclusion and exclusion criteria. The study will be conducted on patients attending the outpatient clinic of the pediatric dentistry department, Faculty of Dental Medicine Al-Azhar.
Who may be able to join
- Participants aged between 4 and 8 years.
- Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique).
- No history of any antibiotic consumption 2 weeks before the procedure.
- No history of fluoride application 2 weeks before the procedure.
Who cannot join
- Special children with physical disabilities or emotional disturbances.
- Children are diagnosed with systemic diseases.
- Grossly destructed teeth with non-restorable crown structure.
- Primary teeth with shedding or pathological tooth mobility.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Al-Azhar University
Cairo, Nasr City
- Not yet recruiting
Faculty of Dental Medicine at Al-Azhar University.
Cairo, Nasr City
Alaa Mohammed Eldehna, assistant proffessor, 02001068837641, alaaaldehna.26@azhar.edu.eg
Aya Sallem, PhD, 00201274067604, ayasalem.26@azhar.edu.eg
About this study
Official title: Evaluation of Oral Hygiene Status in Correlation With Microbial Load in the Oral Cavity Following Restorations of Primary Molars Using Stainless Steel and Bioflex Crowns (Clinical Randomized Trial)
Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out.
- Conditions
- Carious Lesion, Ready-made Crowns
- Being tested
- stainless steel crown, bioflex crown
- Keywords
- primary crowns,, oral health
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stainless steel crownOther
familiar method of managing multi-surface carious lesions in primary teeth
bioflex crownOther
aesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns
| Study group | Role | What they receive |
|---|---|---|
| Group S | teeth subjected to SSC on one side Receives: Other: stainless steel crown | |
| Group B | teeth subjected to Bioflx crowns on the contralateral side Receives: Other: bioflex crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.
Collecting the plaque samples from the gingival crevices, buccal mucosa, and occlusal surfaces of the teeth treated using sterile cotton swabs initially and from the respective crown surfaces. After collecting the samples, they will be inoculated onto a plate of Mitis salivarius-bacitracin agar (MSBA), a selective growth medium for cultivating S. mutans.
Measured: one months
Secondary outcomes (2)
Gingival health
by measuring the gingival index (GI) Gingival Index (GI)
- Purpose: Measures the severity of gingivitis based on the color, consistency, and bleeding of the gums.
- Scoring: 0: Normal gingiva
- Mild inflammation (slight change in color, slight edema, no bleeding).
- Moderate inflammation (redness, edema, and bleeding upon probing).
- Severe inflammation (marked redness and edema, spontaneous bleeding).
Measured: one months
Plaque Index (PI)
- Purpose: Assesses the amount of dental plaque on teeth.
- Scoring:
No plaque
- A film of plaque adhering to the free gingival margin and adjacent areas of the tooth.
- Moderate accumulation of soft deposits on the gingival margin and/or the adjacent tooth surfaces.
- Abundance of soft matter on the tooth and gingival margin.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start5 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious LesionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa M Eldehna, Al-Azhar University
- Investigators
- Alaa Mohammed Eldehna, Assistant Proffessor, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767670
- Sponsor's protocol ID
- P-PD-25-01
- Acronym
- bioflex crown
- Status last verified
- May 2026
- First submitted
- 6 Jan 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Hygiene Status in Correlation With Microbial Load in the Oral Cavity Following Restorations of Primary Molars Using Stainless Steel and Bioflex Crowns (Clinical Randomized Trial)
- ClinicalTrials.gov ID
- NCT06767670
- Acronym / sponsor ID
- bioflex crown / P-PD-25-01
- Conditions
- Carious Lesion, Ready-made Crowns
- Keywords
- primary crowns,, oral health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
Following the restoration of primary molars with stainless steel and bioflex crowns, an evaluation of the current state of oral hygiene in relation to the amount of microorganisms and gingival health in the oral cavity will be carried out.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Other: stainless steel crownteeth subjected to SSC on one side |
| Group B | – | Other: bioflex crownteeth subjected to Bioflx crowns on the contralateral side |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 10 patients 4-8 years old will be selected according to the established inclusion and exclusion criteria. The study will be conducted on patients attending the outpatient clinic of the pediatric dentistry department, Faculty of Dental Medicine Al-Azhar.
Key inclusion criteria (4 listed)
- Participants aged between 4 and 8 years.
- Pulp therapy treated primary molars on the contralateral side, requiring a full coverage restoration (split-mouth technique).
- No history of any antibiotic consumption 2 weeks before the procedure.
- No history of fluoride application 2 weeks before the procedure.
Key exclusion criteria (4 listed)
- Special children with physical disabilities or emotional disturbances.
- Children are diagnosed with systemic diseases.
- Grossly destructed teeth with non-restorable crown structure.
- Primary teeth with shedding or pathological tooth mobility.
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 |
|---|---|---|
| stainless steel crownfamiliar method of managing multi-surface carious lesions in primary teeth | Other | Group S |
| bioflex crownaesthetic preformed pediatric crowns that offer the properties of both stainless steel and zirconia crowns | Other | Group B |
Primary outcome
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions.
Time frame: one months
Collecting the plaque samples from the gingival crevices, buccal mucosa, and occlusal surfaces of the teeth treated using sterile cotton swabs initially and from the respective crown surfaces. After collecting the samples, they will be inoculated onto a plate of Mitis salivarius-bacitracin agar (MSBA), a selective growth medium for cultivating S. mutans.
2 secondary outcomes
Gingival health
Time frame: one months
Plaque Index (PI)
Time frame: one month
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 12 May 2026.
- Individual participant dataSharing planned: Undecided
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This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
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.
Alaa Mohammed Eldehna, Assistant Proffessor principal investigator
Al-Azhar University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carious Lesion and Ready-made Crowns, run by Al-Azhar University at 2 sites 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 4 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Alaa Mohammed Eldehna, Assistant Proffessor (02001068837641, alaaaldehna.26@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adhesion of S. mutans to prefabricated Bioflx and Stainless-steel crowns under clinical conditions. (time frame: one 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 12 May 2026.