18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial

April 19, 2025 updated by: Amera Nabel, Cairo University
The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.

Study Type

Interventional

Enrollment (Estimated)

34

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cervical carious lesions in anterior teeth and premolars
  2. Small to moderate class V carious lesion (ICDAS 3 & 4).
  3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
  4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

  1. Cervical carious lesions in molars.
  2. Deep carious defects (close to pulp, less than 1 mm distance).
  3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  4. Non-vital teeth, Fractured or cracked teeth.
  5. Endodontically treated teeth.
  6. Periodontally affected teeth

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Beautifil Flow Plus F00
Conventional flowable giomer restorative material
Other: Beautifil Flow Plus F00
Conventional flowable giomer restorative material
Experimental: FIT SA
Self adhesive flowable giomer restorative material
Other: FIT SA
self-adhesive flowable giomer restorative material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance
Time Frame: 18 months
Clinical Performance using Modified USPHS criteria
18 months

Collaborators and Investigators

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

Sponsor

Cairo University

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.

Helpful Links

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)

September 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU PhD protocol for Amira

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Subscribe