Dental Restoration FailureNCT05499494
Clinical Evaluation of Bioactive Injectable Resin Composite in Posterior Restorations
A study testing Beautifil Flow Plus X F00 injectable composite and Tetric N ceram resin composite in people with Dental Restoration Failure, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Beautifil Flow Plus X F00 injectable composite and Tetric N ceram resin composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2022to Mar 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants:
- Age range 20-50 years.
- Males Or females .
- Co-operative patients approving to participate in the trial.
- Teeth:
- class I or II carious lesions premolars and molars.
- Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
- Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.
Who cannot join
- Participants:
- Patients with general systemic illness.
- Allergic history against any component of used material.
- Disabilities.
- Pregnancy
- Xerostomia.
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- Lack of compliance.
- Evidence of parafunctional habits.
- Temporomandibular joint disorders.
- Teeth:
- Periapical pathology or signs of pulpal pathology.
- Endodontically treated teeth.
- Tooth hypersensitivity.
- Possible prosthodontic restoration of teeth.
- Heavy occlusion and occlusal contacts or history of bruxism.
- Severe periodontal affection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, Cairo University
Cairo
Mai Mamdouh, PhD, +201066444572, mai_mamdouh@dentistry.cu.edu.eg
About this study
Official title: Clinical Evaluation of Bioactive Injectable Resin Composite Versus Conventional Nanohybrid Composite in Posterior Restorations, 18 m Randomized Controlled Clinical Trial
The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities
Read the detailed description
Statement of the problem:
Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.
The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.
Rationale for carrying out the trial:
The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.
- Conditions
- Dental Restoration Failure
- Being tested
- Beautifil Flow Plus X F00 injectable composite, Tetric N ceram resin composite
- Keywords
- Injectable composite, Nano hybrid composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beautifil Flow Plus X F00 injectable compositeOther
bioactive injectable composite
Tetric N ceram resin compositeOther
Nano hybrid resin composite
| Study group | Role | What they receive |
|---|---|---|
| injectable composite | Experimental | The material will be applied according to manufacturer instructions. BEAUTIFIL Flow Plus X will be applied directly into the cavity and create the shape desired in layers not exceeding 2 mm, and light cured for 20 seconds. Receives: Other: Beautifil Flow Plus X F00 injectable composite |
| Nanohybrid resin composite | Active comparator | The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions. Receives: Other: Tetric N ceram resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the clinical performance
Measured using modified USPHS criteria
Measured: From baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study startAug 2022 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Mohamed El Deriny, Cairo University
- Investigators
- Mai Mamdouh, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499494
- Sponsor's protocol ID
- Injectable resin composite
- Status last verified
- Aug 2022
- First submitted
- 11 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bioactive Injectable Resin Composite Versus Conventional Nanohybrid Composite in Posterior Restorations, 18 m Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05499494
- Acronym / sponsor ID
- Injectable resin composite
- Conditions
- Dental Restoration Failure
- Keywords
- Injectable composite, Nano hybrid composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 12 Aug 2022 (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.
The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities
Detailed description
Statement of the problem:
Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.
The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.
Rationale for carrying out the trial:
The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injectable composite | Experimental | Other: Beautifil Flow Plus X F00 injectable compositeThe material will be applied according to manufacturer instructions. BEAUTIFIL Flow Plus X will be applied directly into the cavity and create the shape desired in layers not exceeding 2 mm, and light cured for 20 seconds. |
| Nanohybrid resin composite | Active comparator | Other: Tetric N ceram resin compositeThe nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants:
- Teeth:
Key exclusion criteria (16 listed)
- Participants:
- 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 |
|---|---|---|
| Beautifil Flow Plus X F00 injectable compositebioactive injectable composite | Other | injectable composite |
| Tetric N ceram resin compositeNano hybrid resin composite | Other | Nanohybrid resin composite |
Primary outcome
Change in the clinical performance
Time frame: From baseline to 18 months
Measured using modified USPHS criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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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.
Mai Mamdouh, PhD 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 study testing Beautifil Flow Plus X F00 injectable composite and Tetric N ceram resin composite in people with Dental Restoration Failure, 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 16 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 Aug 2022. 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 Hazem Elderiny, M.SC (+201007775636, hazem.elderiny@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the clinical performance (time frame: From baseline to 18 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 15 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.