DMENCT06900868
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial
A study testing Assigned Interventions in people with DME and Dental Caries, run by Future University in Egypt.
Trial summary
Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- DME, Dental Caries, Dental
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults patients (20-50)
- Good oral hygiene (plaque index 0 or 1 )
- Patient approving to participate in the study
- Absence of parafunctional habits and/or bruxism
- No sign of irreversible pulpitis
- No periapical radiolucency
- Deep subgingival margin
- Molars class II with subgingival margin
Who cannot join
- • Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
- Bad oral hygiene (plaque index 2 or 3 )
- Heavy smokers
- Patients undergoing or will start orthodontic treatment
- Patients with removable prothesis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).
- Conditions
- DME, Dental Caries, Dental, Deep Margin Elevation
- Being tested
- Assigned Interventions
- Keywords
- Deep margin elevation
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
SDR Smart dentine replacement material nonbioactive
| Study group | Role | What they receive |
|---|---|---|
| arm | Active comparator | Beautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent caries
- 0: no evidence of caries continuous along the margin using periapical radiograph.
- 1: caries evident continuous with the margin of restoration
Measured: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Secondary outcomes (3)
Fracture of Restoration
- 1: Restoration is intact and fully retained.
- 2:Restoration is partially retained with some portion of the restoration still intact.
- 3:Restoration is completely missing
Measured: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Post- operative sensitivity
- 1: Absent
- 2: Present
Measured: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Bleeding on Probing
- 0 :Healthy gums
- 1 :Bleeding on probing
Measured: T0: 1 Week Baseline T1: 6 Months T2: 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 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DMEStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED AYMAN ESMAIL MAHMOUD, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900868
- Sponsor's protocol ID
- Deep marginal elevation
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Felemban MF, Khattak O, Alsharari T, Alzahrani AH, Ganji KK, Iqbal A. Relationship between Deep Marginal Elevation and Periodontal Parameters: A Systematic Review. Medicina (Kaunas). 2023 Nov 3;59(11):1948. doi: 10.3390/medicina59111948.
PubMed 38003997Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
PubMed 35656656
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06900868
- Acronym / sponsor ID
- Deep marginal elevation
- Conditions
- DME, Dental Caries, Dental, Deep Margin Elevation
- Keywords
- Deep margin elevation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 28 Mar 2025 (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.
Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm | Active comparator | Other: Assigned InterventionsBeautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults patients (20-50)
- Good oral hygiene (plaque index 0 or 1 )
- Patient approving to participate in the study
- Absence of parafunctional habits and/or bruxism
- No sign of irreversible pulpitis
Key exclusion criteria (7 listed)
- • Patients with known allergic or adverse reaction to the tested materials.
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 |
|---|---|---|
| Assigned InterventionsSDR Smart dentine replacement material nonbioactive | Other | arm |
Primary outcome
Recurrent caries
Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
* 0: no evidence of caries continuous along the margin using periapical radiograph. * 1: caries evident continuous with the margin of restoration
3 secondary outcomes
Fracture of Restoration
Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Post- operative sensitivity
Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Bleeding on Probing
Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Results publication: PubMed 38003997Felemban MF, Khattak O, Alsharari T, Alzahrani AH, Ganji KK, Iqbal A. Relationship between Deep Marginal Elevation and Periodontal Parameters: A Systematic Review. Medicina (Kaunas). 2023 Nov 3;59(11):1948. doi: 10.3390/medicina59111948.
- Results publication: PubMed 35656656Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with DME and Dental Caries, run by Future University 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 7 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: opening soon, as of the sponsor's last update on 28 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AHMED A Yakop, BDS (00201555134512, Ahmed.yakop66@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent caries (time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900868, which also lists 2 linked publications.
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 Mar 2025.