The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)

April 5, 2025 updated by: Dalia Sameh Fawzi

The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities: A Randomized Clinical Trial

Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients aged (20-50)
  2. Medically free
  3. Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
  4. Patients accepting to participate in the study.
  5. Teeth of normal appearance and morphology
  6. Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.

Exclusion Criteria:

  1. Patients <20 and >50.
  2. Teeth with proximal lesions.
  3. Patients with bad oral hygiene (Plaque index >2).
  4. Systematic disease that may interfere with the study.
  5. Patients with xerostomia.
  6. Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
  7. Patients undergoing or will start orthodontic treatment.
  8. Pregnancy.
  9. Teeth with signs or symptoms of irreversible pulpitis.
  10. Non-vital, fractured or cracked teeth.
  11. Teeth with secondary caries.
  12. Periodontally compromised 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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bioactive injectable composite
bioactive injectable composite placed as a dentine substitute
Other: Beautifil Flow Plus X
Shofu's Beautifil Flow Plus X F00 a advanced bioactive injectable composite
Active Comparator: Short fiber reinforced composite
Short fiber reinforced composite added as a dentine substitute
Other: EverX Flow
Short fiber reinforced composite

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fracture
Time Frame: T1: 1 week T2: 6months T3: 12 months
  1. Clinically excellent/very good (sufficient): Restoration is completely present without deficiencies detectable after air drying.
  2. Clinically good (sufficient): Restoration is completely present with minor deficiencies detectable after air drying
  3. Clinically satisfactory (sufficient): Restoration is present with deficiencies detectable without air drying
  4. Clinically unsatisfactory (partially insufficient): Localized but severe deficiencies regarding fracture and retention
  5. Clinically poor (entirely insufficient): Generalized severe deficiencies
T1: 1 week T2: 6months T3: 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrent caries
Time Frame: T1: 1 week T2: 6months T3: 12 months
  1. Clinically excellent/very good (sufficient): No caries/demineralization at the restoration margin detectable after air drying.
  2. Clinically good (sufficient): First visible signs of a non-cavitated caries lesion at the restoration margin detectable after air drying.
  3. Clinically satisfactory (sufficient): Established, non- cavitated caries lesion or microcavity at the restoration margin detectable without air drying.

  4. Clinically unsatisfactory (partially insufficient):

    Localized dentin cavity at the restoration margin.

  5. Clinically poor (entirely insufficient): Extensive dentin cavity at the restoration margin.
T1: 1 week T2: 6months T3: 12 months
Post operative sensitivity
Time Frame: T1: 1 week T2: 6months T3: 12 months
  1. Clinically excellent/very good (sufficient): No Postoperative hypersensitivity.
  2. Clinically good (sufficient): Minor postoperative hypersensitivity.
  3. Clinically satisfactory (sufficient) Distinct "moderate" postoperative hypersensitivity.
  4. Clinically unsatisfactory (partially insufficient): Severe "persistent" postoperative hypersensitivity.
  5. Clinically poor (entirely insufficient): Extreme postoperative hypersensitivity "Irreversible pulpitis".
T1: 1 week T2: 6months T3: 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dalia Sameh Fawzi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Restoring Deep Occlusal Cavity

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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