The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: a Randomized Clinical Trial

March 22, 2025 updated by: AHMED AYMAN ESMAIL MAHMOUD, Future University in Egypt
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: arm
Beautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material
Other: Assigned Interventions
SDR Smart dentine replacement material nonbioactive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
T0: 1 Week Baseline T1: 6 Months T2: 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture of Restoration
Time Frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months
  • 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
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
  • 1: Absent
  • 2: Present
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
  • 0 :Healthy gums
  • 1 :Bleeding on probing
T0: 1 Week Baseline T1: 6 Months T2: 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2025

Primary Completion (Estimated)

April 20, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Deep marginal elevation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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