Carious Teeth2-YearNCT06226389
Clinical Evaluation of Different Bulk-fill Composite Restorations on Posterior Teeth
A study testing Flowable bulk-fill resin composite, preheated bulk-fill resin composite and sonic bulk-fill resin composite in people with Carious Teeth, run by Mansoura University at 1 site in Egypt.
Trial summary
Different bulk-fill composites will be applied in different posterior cavities then compared Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Teeth
- What is being tested?
- Flowable bulk-fill resin composite, preheated bulk-fill resin composite and sonic bulk-fill resin composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Jan 2026
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 4 carious molars
Who cannot join
- pregnancy patient
- Not able to regularly follow up
- bad oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2-Year Clinical Evaluation of Different Bulk-fill Resin Composite Restorative Systems in Posterior Teeth
Different bulk-fill composites will be applied in different posterior cavities then compared
Read the detailed description
Patients must be in middle age(25-55) age,able to regularly follow up,not pregnant and at least have 4 carious molars
- Conditions
- Carious Teeth
- Being tested
- Flowable bulk-fill resin composite, preheated bulk-fill resin composite, sonic bulk-fill resin composite, conventional bulk-fill resin composite
- Keywords
- Bulk-fill composite, posterior cavities
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flowable bulk-fill resin compositeProcedure or surgery
Flowable bulk-fill resin composite material used for posterior restorations
preheated bulk-fill resin compositeProcedure or surgery
preheated bulk-fill resin composite material used for posterior restorations
sonic bulk-fill resin compositeProcedure or surgery
sonic bulk-fill resin composite material used for posterior restorations
conventional bulk-fill resin compositeProcedure or surgery
conventional bulk-fill resin composite material used for posterior restorations
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:flowable Bulk-fill composite | Experimental | Posterior cavities restored using a flowable bulk-fill resin composite placed in a single increment according to the manufacturer's instruction Receives: Procedure: Flowable bulk-fill resin composite |
| Preheated bulk-fill composite | Experimental | Posterior cavities restored using a preheated bulk-fill resin composite placed in a single increment according to the manufacturer's instruction Receives: Procedure: preheated bulk-fill resin composite |
| sonic activated bulk-fill composite | Experimental | Posterior cavities restored using a sonic bulk-fill resin composite placed in a single increment according to the manufacturer's instruction Receives: Procedure: sonic bulk-fill resin composite |
| conventional bulk-fill composite | Experimental | Posterior cavities restored using a conventional bulk-fill resin composite placed in a single increment according to the manufacturer's instruction Receives: Procedure: conventional bulk-fill resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between baseline and after 2 years of evaluation of resin based composite
Change in FDI criteria
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asmaa S Elsaeed, Assistant lecturer, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226389
- Sponsor's protocol ID
- A02011023
- Acronym
- 2-Year
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes Study Protocol, Statistical Analysis Plan can be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-Year Clinical Evaluation of Different Bulk-fill Resin Composite Restorative Systems in Posterior Teeth
- ClinicalTrials.gov ID
- NCT06226389
- Acronym / sponsor ID
- 2-Year / A02011023
- Conditions
- Carious Teeth
- Keywords
- Bulk-fill composite, posterior cavities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 26 Jan 2024 (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.
Different bulk-fill composites will be applied in different posterior cavities then compared
Detailed description
Patients must be in middle age(25-55) age,able to regularly follow up,not pregnant and at least have 4 carious molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1:flowable Bulk-fill composite | Experimental | Procedure: Flowable bulk-fill resin compositePosterior cavities restored using a flowable bulk-fill resin composite placed in a single increment according to the manufacturer's instruction |
| Preheated bulk-fill composite | Experimental | Procedure: preheated bulk-fill resin compositePosterior cavities restored using a preheated bulk-fill resin composite placed in a single increment according to the manufacturer's instruction |
| sonic activated bulk-fill composite | Experimental | Procedure: sonic bulk-fill resin compositePosterior cavities restored using a sonic bulk-fill resin composite placed in a single increment according to the manufacturer's instruction |
| conventional bulk-fill composite | Experimental | Procedure: conventional bulk-fill resin compositePosterior cavities restored using a conventional bulk-fill resin composite placed in a single increment according to the manufacturer's instruction |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 4 carious molars
Key exclusion criteria (3 listed)
- pregnancy patient
- Not able to regularly follow up
- bad oral hygiene
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 |
|---|---|---|
| Flowable bulk-fill resin compositeFlowable bulk-fill resin composite material used for posterior restorations | Procedure or surgery | Arm 1:flowable Bulk-fill composite |
| preheated bulk-fill resin compositepreheated bulk-fill resin composite material used for posterior restorations | Procedure or surgery | Preheated bulk-fill composite |
| sonic bulk-fill resin compositesonic bulk-fill resin composite material used for posterior restorations | Procedure or surgery | sonic activated bulk-fill composite |
| conventional bulk-fill resin compositeconventional bulk-fill resin composite material used for posterior restorations | Procedure or surgery | conventional bulk-fill composite |
Primary outcome
Difference between baseline and after 2 years of evaluation of resin based composite
Time frame: Baseline to 2 years
Change in FDI criteria
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 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Yes Study Protocol, Statistical Analysis Plan can be shared to other researchers
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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.
Asmaa S Elsaeed, Assistant lecturer principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flowable bulk-fill resin composite, preheated bulk-fill resin composite and sonic bulk-fill resin composite in people with Carious Teeth, run by Mansoura 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 1 inclusion and 3 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 29 Apr 2026. 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?
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?
Difference between baseline and after 2 years of evaluation of resin based composite (time frame: Baseline to 2 years). 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 29 Apr 2026.