Caries Class IIEarly Phase 1NCT04019145
Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite
A Early Phase 1 study testing EverX Posterior and Resins, Composite in people with Caries Class II, run by Cairo University at 1 site in Egypt.
Trial summary
A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Class II
- What is being tested?
- EverX Posterior and Resins, Composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Sep 2021
- Phase
- Early Phase 1
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Patients consulting in one of the outpatient clinic listed above.
- Able to tolerate necessary restorative procedures.
- Provide informed consent.
- Accepts the one year follow-up period.
- Tooth related criteria:
- Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
- Teeth are vital according to pulp-sensitivity tests.
Who cannot join
- Patient-related criteria:
- Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
- Tooth related criteria:
Show all 12Show fewer
- Deciduous teeth; as the study is targeting only permanent teeth.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
- Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
- Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Fiber Reinforced Bulk Fill Resin Composite Versus Incremental Packing of Nanohybrid Resin Composite in Restoration of Deep Proximal Lesions of Permanent Posterior Molars: A Randomized Controlled Trial
A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.
Read the detailed description
The aim of this study is to conduct an RCT to evaluate the clinical performance of the fiber reinforced bulk fill resin composite in comparison to incremental packing of nanohybrid resin composite.
Examination and selection of all patients will be done according to inclusion and exclusion criteria. Diagnosis of patients' chief complaint and teeth that will be involved in this study will be done. Teeth are to be chosen according to standardized radiographic examination. Teeth should have proximal, primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
A Class II cavity will be prepared after local anesthesia has been given as required. The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes. Sharp excavators will allow accessible removal of soft carious lesions will be used. Any tooth that will suffer from pulpal exposure will be excluded from the study. Finishing of the cavity walls will be done using a fine-grit, yellow coded, diamond bur.
Rubber dam isolation will be done.
Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.
A closed centripetal technique will be utilized, where a proximal wall will be built using nanohyrbid resin composite first, followed by filling of cavity with bulk-fill fiber reinforced resin composite material in increments of 3-4mm, as required to end up with leaving an occlusal space on top of at least 2mm. Then, an occlusal increment of nanohybrid resin composite will be applied. Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions.
A closed centripetal, oblique incrementation technique will be used to completely fill the whole cavity. Increments should be of 2mm thickness or less and should be placed obliquely from the cavity walls. Then finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions
Outcome Measuring Device: modified USPHS criteria .
Primary Outcomes:
Mechanical evaluation:
Fracture and Retention Marginal integrity Marginal Discoloration Anatomic Form Surface Texture Proximal Contact Radiographic Examination
Secondary Outcomes:
Biological evaluation:
Postoperative Sensitivity Recurrent Caries
- Conditions
- Caries Class II
- Being tested
- EverX Posterior, Resins, Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverX PosteriorDrug
Also called Fiber reinforced bulk fill dentine substitute
fiber reinforced bulk fill resin composite
Resins, CompositeDrug
Also called Universal Restorative Nanohybrid resin composite
incremental packing of Nanohybrid Resin composite
| Study group | Role | What they receive |
|---|---|---|
| Fiber Reinforced bulk fill resin composite | Experimental | Fiber reinforced bulk fill resin composite dentine substitute, capped occlusally and proximally (closed centripetal technique) by nanohybrid resin composite. Receives: Drug: EverX Posterior |
| nanohybrid resin composite incrementation | Active comparator | Nanohybrid resin composite layering to fill the whole cavity, using closed centripetal technique. Receives: Drug: Resins, Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical outcome according to USPHS criteria
fracture or retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, radiographic examination and surface texture
Measured: 12 months
Secondary outcomes (1)
Biological outcome according to USPHS criteria
postoperative sensitivity and recurrent caries
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 posted15 Jul 2019
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Class IIStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Salem, Cairo University
- Investigators
- Olfat Hassanein, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019145
- Sponsor's protocol ID
- 28909092104862
- Status last verified
- Nov 2021
- First submitted
- 10 Jul 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fiber Reinforced Bulk Fill Resin Composite Versus Incremental Packing of Nanohybrid Resin Composite in Restoration of Deep Proximal Lesions of Permanent Posterior Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04019145
- Acronym / sponsor ID
- 28909092104862
- Conditions
- Caries Class II
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Jul 2019 (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.
A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.
Detailed description
The aim of this study is to conduct an RCT to evaluate the clinical performance of the fiber reinforced bulk fill resin composite in comparison to incremental packing of nanohybrid resin composite.
Examination and selection of all patients will be done according to inclusion and exclusion criteria. Diagnosis of patients' chief complaint and teeth that will be involved in this study will be done. Teeth are to be chosen according to standardized radiographic examination. Teeth should have proximal, primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
A Class II cavity will be prepared after local anesthesia has been given as required. The cavity will be prepared using a high-speed hand-piece with air and water coolant and diamond burs of different sizes. Sharp excavators will allow accessible removal of soft carious lesions will be used. Any tooth that will suffer from pulpal exposure will be excluded from the study. Finishing of the cavity walls will be done using a fine-grit, yellow coded, diamond bur.
Rubber dam isolation will be done.
Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.
A closed centripetal technique will be utilized, where a proximal wall will be built using nanohyrbid resin composite first, followed by filling of cavity with bulk-fill fiber reinforced resin composite material in increments of 3-4mm, as required to end up with leaving an occlusal space on top of at least 2mm. Then, an occlusal increment of nanohybrid resin composite will be applied. Finally finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions.
A closed centripetal, oblique incrementation technique will be used to completely fill the whole cavity. Increments should be of 2mm thickness or less and should be placed obliquely from the cavity walls. Then finishing and occlusal adjustment will be done under water spray by using superfine diamond burs. Polishing will be done using pre-impregnated rubber cups. Materials will be manipulated according to manufacturer instructions
Outcome Measuring Device: modified USPHS criteria .
Primary Outcomes:
Mechanical evaluation:
Fracture and Retention Marginal integrity Marginal Discoloration Anatomic Form Surface Texture Proximal Contact Radiographic Examination
Secondary Outcomes:
Biological evaluation:
Postoperative Sensitivity Recurrent Caries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiber Reinforced bulk fill resin composite | Experimental | Drug: EverX PosteriorFiber reinforced bulk fill resin composite dentine substitute, capped occlusally and proximally (closed centripetal technique) by nanohybrid resin composite. |
| nanohybrid resin composite incrementation | Active comparator | Drug: Resins, CompositeNanohybrid resin composite layering to fill the whole cavity, using closed centripetal technique. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients consulting in one of the outpatient clinic listed above.
- Able to tolerate necessary restorative procedures.
- Provide informed consent.
- Accepts the one year follow-up period.
- Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
Key exclusion criteria (12 listed)
- Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs cannot be taken for them.
- Allergy to any of the restorative materials, including anesthetics.
- Uncooperative patients, will not abide by the instructions or attend the appointments.
- Deciduous teeth; as the study is targeting only permanent teeth.
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 |
|---|---|---|
| EverX PosteriorAlso: Fiber reinforced bulk fill dentine substitutefiber reinforced bulk fill resin composite | Drug | Fiber Reinforced bulk fill resin composite |
| Resins, CompositeAlso: Universal Restorative Nanohybrid resin compositeincremental packing of Nanohybrid Resin composite | Drug | nanohybrid resin composite incrementation |
Primary outcome
Mechanical outcome according to USPHS criteria
Time frame: 12 months
fracture or retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, radiographic examination and surface texture
1 secondary outcome
Biological outcome according to USPHS criteria
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Olfat Hassanein, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EverX Posterior and Resins, Composite in people with Caries Class II, run by Cairo 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 8 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: finished, as of the sponsor's last update on 9 Nov 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mechanical outcome according to USPHS criteria (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 9 Nov 2021.