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

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

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
Intervention / Treatment
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

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

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

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)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

April 5, 2025

First Posted (Actual)

April 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID 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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