Dental Caries in ChildrenNCT05902975
Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
A study testing Fiber reinforced composite resin space maintainer in people with Dental Caries in Children, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Fiber reinforced composite resin space maintainer Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Fiber reinforced composite resin space maintainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2022to 15 Jul 2023
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature loss of primary molar.
- Presence of teeth on the mesial and distal sides of the extraction space.
- Normal primary molar relation.
- No root resorption of abutment teeth.
- Presence of a succedaneous tooth bud.
- Absence of pathology on the eruption track of the succedaneous tooth.
- The age will be ranged from 4 to 9 years.
Who cannot join
- Carious buccal and lingual surface of abutment teeth.
- Absence of teeth on the mesial and distal sides of the extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Fiber reinforced composite resin space maintainer
Read the detailed description
Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.
- Conditions
- Dental Caries in Children
- Being tested
- Fiber reinforced composite resin space maintainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber reinforced composite resin space maintainerDevice
Bonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation
| Study group | Role | What they receive |
|---|---|---|
| Fiber reinforced composite space maintainer | Experimental | 12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle. Receives: Device: Fiber reinforced composite resin space maintainer |
| Fiber reinforced space maintainer with silver nano particles | Experimental | 12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles. Receives: Device: Fiber reinforced composite resin space maintainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
Streptococcus mutants : One loop (1/1000th ml of sample) was inoculated on the Mitis Salivarius (MSA)* agar with 0.2 U/ml bacitracin and sucrose (15% w/v) bacitracin. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(10) For determination of S. mutans count: After 48 h , colony characteristics were studied and the number of colony forming units of SM (CFU/ml) in saliva was determined manually .
Lactobacilli : One loop (1/1000th ml of sample) was inoculated on the Rogosa **SL agar plate. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(11) For determination of lactobacilli count: After 48 h , colony characteristics were studied and the number of colony forming units of lactobacilli (CFU/ml) in saliva was determined manually
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start21 May 2022
- Primary completion15 May 2023
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Nada Mohamed Elsadany, Al-Azhar University
- Investigators
- Alaa eldin Mahmoud Abdallah, Study director, Associate professiorHamdy Mahmoud Badereldin, Study director, LectureAhmed Akram Elawady, Study director, Lecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902975
- Sponsor's protocol ID
- Space maintainer
- Status last verified
- Jun 2023
- First submitted
- 21 May 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antimicrobial Fiber Reinforced Composite Resin Space Maintainer Modified With Silver Nano Particles
- ClinicalTrials.gov ID
- NCT05902975
- Acronym / sponsor ID
- Space maintainer
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 21 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
Fiber reinforced composite resin space maintainer
Detailed description
Evaluation of the antimicrobial fiber reinforced composite resin space maintainer modified by silver nano particles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber reinforced composite space maintainer | Experimental | Device: Fiber reinforced composite resin space maintainer12 children received fiber reinforced composite (FRC) space maintainer without silver nanoparticle. |
| Fiber reinforced space maintainer with silver nano particles | Experimental | Device: Fiber reinforced composite resin space maintainer12 children received fiber reinforced composite (FRC) space maintainers modified with silver nanoparticles. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Premature loss of primary molar.
- Presence of teeth on the mesial and distal sides of the extraction space.
- Normal primary molar relation.
- No root resorption of abutment teeth.
- Presence of a succedaneous tooth bud.
Key exclusion criteria (2 listed)
- Carious buccal and lingual surface of abutment teeth.
- Absence of teeth on the mesial and distal sides of the extraction.
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 |
|---|---|---|
| Fiber reinforced composite resin space maintainerBonding of fiber reinforced with composite resin on primary second molar and primary canine under rubber dam isolation | Device | Fiber reinforced composite space maintainer, Fiber reinforced space maintainer with silver nano particles |
Primary outcome
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva
Time frame: 6 month
Streptococcus mutants : One loop (1/1000th ml of sample) was inoculated on the Mitis Salivarius (MSA)* agar with 0.2 U/ml bacitracin and sucrose (15% w/v) bacitracin. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(10) For determination of S. mutans count: After 48 h , colony characteristics were studied and the number of colony forming units of SM (CFU/ml) in saliva was determined manually . Lactobacilli : One loop (1/1000th ml of sample) was inoculated on the Rogosa **SL agar plate. The plates were incubated aerobically ( 5% CO2) at 37°C for 48 h.(11) For determination of lactobacilli count: After 48 h , colony characteristics were studied and the number of colony forming units of lactobacilli (CFU/ml) in saliva was determined manually
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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. This study is not recruiting at the moment.
Alaa eldin Mahmoud Abdallah study director
Associate professior
Hamdy Mahmoud Badereldin study director
Lecture
Ahmed Akram Elawady study director
Lecture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber reinforced composite resin space maintainer in people with Dental Caries in Children, run by Al-Azhar University 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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?
Results are not available in the source record.
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?
Evaluation of strepetoccous mutant and lactobacilli from sample of saliva (time frame: 6 month). 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 15 Jun 2023.