Decay, DentalNCT04720638
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT
A study testing Short fiber reinforced flowable resin composite restorations and Conventional resin composite restoration in people with Decay, Dental and Caries Class II, run by Cairo University at 1 site in Egypt.
Trial summary
Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial). Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Decay, Dental, Caries Class II
- What is being tested?
- Short fiber reinforced flowable resin composite restorations and Conventional resin composite restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2021to Jun 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 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with large proximal carious cavities in molars.
- Pulp asymptomatic vital carious upper or lower molars.
- Good oral hygiene.
Who cannot join
- Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
- Severe medical complications.
- Allergic history concerning methacrylates
- Evidence of parafunctional habits.
Trial locations and contacts
1 site in 1 country.
Sherifa Ahmed contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 11331
Rawda Hesham Abd ElAziz, 01001097200, rawda.hesham@dentistry.cu.edu.eg
About this study
Official title: Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)
Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).
- Conditions
- Decay, Dental, Caries Class II
- Being tested
- Short fiber reinforced flowable resin composite restorations, Conventional resin composite restoration
- Keywords
- short fiber reinforced flowable resin composite, Clinical performance, Ever X flow, Randomized clinical study
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short fiber reinforced flowable resin composite restorationsOther
Also called Ever X Flow
reinforced flowable resin composite
Conventional resin composite restorationOther
Also called Gaenial posterior, GC Europe
Microhybrid resin composite
| Study group | Role | What they receive |
|---|---|---|
| Short fiber reinforced flowable resin composite restorations | Experimental | (everX Flow, GC Europe) + (Gaenial posterior, GC Europe Receives: Other: Short fiber reinforced flowable resin composite restorations |
| Conventional resin composite restoration. | Active comparator | (Gaenial posterior, GC Europe) Receives: Other: Conventional resin composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance (Alpha is the best score, bravo, charlie the worst score)
Modified USPHS criteria; . Post operative Hypersensitivity
Secondary caries
Gross fracture
Color match
Cavo-surface marginal discoloration
Marginal integrity
Proximal contact
Measured: Change from baseline at 6, 12 ,18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startMar 2021 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decay, DentalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawda Hesham Abd ElAziz, Cairo University
- Investigators
- Rawda Hesham, Principal investigator, Lecturer at faculty of Dentistry- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720638
- Sponsor's protocol ID
- CU-1-2021
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations Versus Conventional Resin Composite Restorations in Posterior Teeth (2y Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04720638
- Acronym / sponsor ID
- CU-1-2021
- Conditions
- Decay, Dental, Caries Class II
- Keywords
- short fiber reinforced flowable resin composite, Clinical performance, Ever X flow, Randomized clinical study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Jan 2021 (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.
Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short fiber reinforced flowable resin composite restorations | Experimental | Other: Short fiber reinforced flowable resin composite restorations(everX Flow, GC Europe) + (Gaenial posterior, GC Europe |
| Conventional resin composite restoration. | Active comparator | Other: Conventional resin composite restoration(Gaenial posterior, GC Europe) |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with large proximal carious cavities in molars.
- Pulp asymptomatic vital carious upper or lower molars.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
- Severe medical complications.
- Allergic history concerning methacrylates
- Evidence of parafunctional habits.
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 |
|---|---|---|
| Short fiber reinforced flowable resin composite restorationsAlso: Ever X Flowreinforced flowable resin composite | Other | Short fiber reinforced flowable resin composite restorations |
| Conventional resin composite restorationAlso: Gaenial posterior, GC EuropeMicrohybrid resin composite | Other | Conventional resin composite restoration. |
Primary outcome
Clinical performance (Alpha is the best score, bravo, charlie the worst score)
Time frame: Change from baseline at 6, 12 ,18, 24 months
Modified USPHS criteria; . Post operative Hypersensitivity Secondary caries Gross fracture Color match Cavo-surface marginal discoloration Marginal integrity Proximal contact
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 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.
Sherifa Ahmed contact
Rawda Hesham principal investigator
Lecturer at faculty of Dentistry- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short fiber reinforced flowable resin composite restorations and Conventional resin composite restoration in people with Decay, Dental and 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 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 26 Jan 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.
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 Rawda Hesham A ElAziz (01001097200, rawda.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical performance (Alpha is the best score, bravo, charlie the worst score) (time frame: Change from baseline at 6, 12 ,18, 24 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 26 Jan 2021.