Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation (Randomized)

March 8, 2025 updated by: Sherif Hamza, Future University in Egypt

Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation Randomized Controlled Trail

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).

This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.

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:

  1. Adult Patient (20-50 years old)
  2. Good oral hygiene (plaque index 0 or 1)
  3. Patient approval
  4. Absence of parafunctional habits and/or bruxism
  5. No endodontic treatment
  6. No abscess
  7. No partial or fixed denture

Exclusion Criteria:

  1. Patients with known allergic or adverse reaction to the tested materials.
  2. Bad oral hygiene
  3. Systematic disease that may affect participation.
  4. Xerostomic patients.
  5. Patients with active periodontal disease.
  6. Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)
  7. Orthodontic treatment patient

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bioactive injectable giomer
Deep margin elevation and subsequent restoration will be done using bioactive giomer material
Other: Beautifil F00
Beautifil F00 is bioactive giomer resin composite.
Active Comparator: Nanohybrid injectable composite
Other: G-aenial Universal Injectable Flowable Composite
Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent caries
Time Frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months
  • 0: no evidence of caries continuous along the margin
  • 1: caries evident continuous with the margin of restoration
T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing
Time Frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

  1. Post-operative sensitivity.

    • 1: Absent
    • 2: Present

  2. 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

  3. Bleeding on probing

    • 0: Healthy gums
    • 1: Bleeding on probing 2:periodontal problem with bone loss
T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 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 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Deep margin 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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