Retention Rate of Flowable Composite in Demenerlized Pits and FissureNCT03264105
Retention Rate of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional
A study testing Hydroxyapatite Nanofiber reinforced flowable composite and conventional resin-based flowable composite in people with Retention Rate of Flowable Composite in Demenerlized Pits and Fissure, run by Cairo University.
Trial summary
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth .Several materials and techniques have been developed to enhance the longevity of pit-and-fissure… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retention Rate of Flowable Composite in Demenerlized Pits and Fissure
- What is being tested?
- Hydroxyapatite Nanofiber reinforced flowable composite and conventional resin-based flowable composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should be over 18 Years old. Patient should have good oral hygiene and general health. Patient with at least 2 non-cavitated initial occlusal carious lesion in 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 cavitated carious lesion. Previously placed sealants or restorations. Bruxism or malocclusion.
About this study
Official title: Retention Rate 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
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth .Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants
Read the detailed description
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures makes them an ideal site for retention of bacteria and food remnants, rendering the performance of proper hygiene difficult or even impossible .
Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants . However, the clinical longevity of flowable composite as fissure sealants is directly related to their retention, where the percentage of rate of retention differ on a 12-month follow-up examination were the partial loss rate of flowable composite material ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate isolation, conditioning of enamel, application techniques, particular material characteristics like viscosity, surface tension, adequate adhesion and penetration of the material into the previously etched system of fissures.
In order to overcome the shortcomings of traditional dental composites, nanofibers or nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are calcium phosphates fillers that allow the release of mineral from dental resin composite. Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and thin structure, and create a lot of bonding points in the interface with polymeric matrix. When the composites suffer from huge pressure this allow tremendous stress transfer from weak polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties of resin composite. So this study will examine the effect of adding HAP nanofibers on the clinical performances and retention rate of flowable resin composite.
- Being tested
- Hydroxyapatite Nanofiber reinforced flowable composite, conventional resin-based flowable composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyapatite Nanofiber reinforced flowable compositeOther
retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite
conventional resin-based flowable compositeOther
retention rate evaluation of conventional resin-based flowable composite
| Study group | Role | What they receive |
|---|---|---|
| NovaPro™ Flow | Experimental | NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA Receives: Other: Hydroxyapatite Nanofiber reinforced flowable composite; Other: conventional resin-based flowable composite |
| Conventional resin-based flowable composite | Active comparator | Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA Receives: Other: Hydroxyapatite Nanofiber reinforced flowable composite; Other: conventional resin-based flowable composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate evaluation of both restoration
restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed.
Totally lost (TL): no trace of materials was detected on the surface.
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 posted28 Aug 2017
- Study startDec 2017 (estimated)
- Primary completionJul 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 Retention Rate of Flowable Composite in Demenerlized Pits and FissureStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safinaz hussien fahmy hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264105
- Sponsor's protocol ID
- CEBC-CU-2017-07-31
- Status last verified
- Aug 2017
- First submitted
- 30 Jul 2017
- Last updated
- 28 Aug 2017
- 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 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rate 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
- NCT03264105
- Acronym / sponsor ID
- CEBC-CU-2017-07-31
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 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.
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth .Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants
Detailed description
Pits and fissures have been considered as the single most important feature leading to the development of occlusal caries; About 90 % of carious lesions are found in the pits and fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures makes them an ideal site for retention of bacteria and food remnants, rendering the performance of proper hygiene difficult or even impossible .
Several materials and techniques have been developed to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure sealants . However, the clinical longevity of flowable composite as fissure sealants is directly related to their retention, where the percentage of rate of retention differ on a 12-month follow-up examination were the partial loss rate of flowable composite material ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate isolation, conditioning of enamel, application techniques, particular material characteristics like viscosity, surface tension, adequate adhesion and penetration of the material into the previously etched system of fissures.
In order to overcome the shortcomings of traditional dental composites, nanofibers or nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are calcium phosphates fillers that allow the release of mineral from dental resin composite. Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and thin structure, and create a lot of bonding points in the interface with polymeric matrix. When the composites suffer from huge pressure this allow tremendous stress transfer from weak polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties of resin composite. So this study will examine the effect of adding HAP nanofibers on the clinical performances and retention rate of flowable resin composite.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovaPro™ Flow | Experimental | Other: Hydroxyapatite Nanofiber reinforced flowable composite, Other: conventional resin-based flowable compositeNovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA |
| Conventional resin-based flowable composite | Active comparator | Other: Hydroxyapatite Nanofiber reinforced flowable composite, Other: conventional resin-based flowable compositeFiltek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients should be over 18 Years old. Patient should have good oral hygiene and general health. Patient with at least 2 non-cavitated initial occlusal carious lesion in first and/or second molar teeth in each quadrant of maxilla or mandible.
Key exclusion criteria (1 listed)
- Known allergy to any of the resins used. Clinically detectable cavitated carious lesion. 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 |
|---|---|---|
| Hydroxyapatite Nanofiber reinforced flowable compositeretention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite | Other | Conventional resin-based flowable composite, NovaPro™ Flow |
| conventional resin-based flowable compositeretention rate evaluation of conventional resin-based flowable composite | Other | Conventional resin-based flowable composite, NovaPro™ Flow |
Primary outcome
retention rate evaluation of both restoration
Time frame: 12 months
restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. Totally lost (TL): no trace of materials was detected on the surface.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyapatite Nanofiber reinforced flowable composite and conventional resin-based flowable composite in people with Retention Rate of Flowable Composite in Demenerlized Pits and Fissure, 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 1 inclusion and 1 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 28 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?
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?
retention rate evaluation of both restoration (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 28 Aug 2017.