Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable CompositeNCT03242291
Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
A study testing Conventional resin-based flowable composite and Hydroxyapatite Nanofiber reinforced flowable composite in people with Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite, run by Cairo University.
Trial summary
This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite
- What is being tested?
- Conventional resin-based flowable composite and Hydroxyapatite Nanofiber reinforced flowable composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Dec 2018
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients should be over 18 Years old.
- Patient should have good oral hygiene and general health
- With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible
Who cannot join
- Known allergy to any of the resins used,
- Clinically detectable caries,
- Previously placed sealants or restorations,
- Bruxism or malocclusion
Trial locations and contacts
No sites are listed yet.
About this study
This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.
Read the detailed description
A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria
- Being tested
- Conventional resin-based flowable composite, Hydroxyapatite Nanofiber reinforced flowable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional resin-based flowable compositeOther
assessment of marginal integrity of Conventional resin-based flowable composite
Hydroxyapatite Nanofiber reinforced flowable compositeOther
assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
| Study group | Role | What they receive |
|---|---|---|
| conventional resin-based flowable composite | Active comparator | Not described Receives: Other: Conventional resin-based flowable composite; Other: Hydroxyapatite Nanofiber reinforced flowable composite |
| Hydroxyapatite Nanofiber reinforced flowable composite | Other | Not described Receives: Other: Conventional resin-based flowable composite; Other: Hydroxyapatite Nanofiber reinforced flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal integrity of both restorations
restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startDec 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable CompositeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, donia elshafey, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242291
- Sponsor's protocol ID
- CEBC-CU-2017-7-29
- Status last verified
- Aug 2017
- First submitted
- 31 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03242291
- Acronym / sponsor ID
- CEBC-CU-2017-7-29
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 Aug 2017 (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 study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.
Detailed description
A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional resin-based flowable composite | Active comparator | Other: Conventional resin-based flowable composite, Other: Hydroxyapatite Nanofiber reinforced flowable composite |
| Hydroxyapatite Nanofiber reinforced flowable composite | Other | Other: Conventional resin-based flowable composite, Other: Hydroxyapatite Nanofiber reinforced flowable composite |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients should be over 18 Years old.
- Patient should have good oral hygiene and general health
- With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible
Key exclusion criteria (4 listed)
- Known allergy to any of the resins used,
- Clinically detectable caries,
- Previously placed sealants or restorations,
- Bruxism or malocclusion
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 |
|---|---|---|
| Conventional resin-based flowable compositeassessment of marginal integrity of Conventional resin-based flowable composite | Other | Hydroxyapatite Nanofiber reinforced flowable composite, conventional resin-based flowable composite |
| Hydroxyapatite Nanofiber reinforced flowable compositeassessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite | Other | Hydroxyapatite Nanofiber reinforced flowable composite, conventional resin-based flowable composite |
Primary outcome
marginal integrity of both restorations
Time frame: 12 months
restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional resin-based flowable composite and Hydroxyapatite Nanofiber reinforced flowable composite in people with Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite, 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 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact donia mamdouh elshafey, master (01008820027 ext. 002, doniaelshafey90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal integrity of both restorations (time frame: 12 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 8 Aug 2017.