Clinical Performance of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Deep Carious Lesions. (GSE)

January 13, 2025 updated by: Marwah Faker Mohammed Al-Emad, Cairo University

Clinical Performance and Radiographic Assessment of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Vital Teeth With Deep Occlusal Carious Lesions. "18-M Randomized Clinical Trial"

This study will evaluate the clinical and radiographic performance of resin composite restoration after utilized a grape seed extract as dentin biomodification in vital teeth with deep occlusal carious lesions (ICDAS 5-6) after selective soft dentin removal technique.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In dentistry, treating deep carious lesions in vital permanent teeth is one of the most contentious issues. Traditional management of such lesions often compromises the tooth structure and exposes the pulp, necessitating further invasive options such as endodontic treatment. Untreated deep carious lesions can result in significant pain and discomfort. Therefore, certain individuals may decide on tooth extraction rather than undergoing treatment.

The International Caries Consensus Collaboration (ICCC) group strongly recommends selective removal of soft dentine (SRSD) in deep-cavitated lesions that extend into dentin tissue. The one-stage partial caries removal technique involves selective removal to soft dentine (SRSD), which involves removing peripheral carious tissue to firm dentin. This process ensures hermetic sealing of the restoration and leaves a layer of soft carious tissue over the pulp to prevent pulpal exposure.

Recent studies have concentrated on the capacity of medicinal plants and their extracts to remineralize dentin. This process isn't simply a matter of spontaneous precipitation or mineral nucleation but involves the growth of existing crystals within the dentin lesion . Proanthocyanidin-rich grape seed extract (PA-rich GSE) is one promising example that is able to remineralize demineralized dentin, enhance collagen interaction, improve mineral density, preserve collagen matrix, and inhibit matrix metalloproteinases (MMPs) and exhibit low toxicity, making it a suitable candidate for intraoral application.

Study Type

Interventional

Enrollment (Estimated)

60

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:

  • Patient-related criteria:

    1. Adult patients (age: 22-42 years) of both genders.
    2. Good oral hygiene.
    3. Willing to sign the informed consent.
    4. Co-operative patients who accept the follow-up period.

  • Tooth-related criteria:

    1. Posterior permanent caries (ICDAS 5&6).
    2. Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
    3. Sensible teeth according to cold pulp test.
    4. Negative response in percussion test.

Exclusion Criteria:

  • Patient-related criteria:

    1. Allergy to any of the restorative materials.
    2. Patients undergoing orthodontic treatment with fixed appliances.
    3. Pregnant women.
    4. Patients with debilitating systemic diseases.
    5. Patient who frequently use analgesic or any drugs that could mask the pain.

  • Tooth-related criteria:

    1. Teeth with previous restorations.
    2. Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
    3. Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
    4. Mobile teeth, indicating periodontal disease or trauma.
    5. External or internal resorption.
    6. Chipped teeth or Cuspal loss

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier.
Experimental: Intervention group
Application of resin composite restoration after partial caries removal with application of 15% GSE as dentin pretreatment.
Other: 15% Grape seed extract as dentin pretreatment
using proanthocyanidin-rich grape seed extract as a biomodifier for dentin improved the mechanical properties of dental collagen by cross-linking and dehydrating fibrils. This made the collagen substrate more suitable for hybridization. It also acted as a non-specific MMP-inhibitor, protecting exposed collagen fibrils from biodegradation from dentin proteases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Performance (Biological properties), Revised FDI criteria. (Clinically excellent-Success rate)
Time Frame: 18 month

Postoperative hypersensitivity and pulpal status/ Caries at restoration margins (CAR), Scores

  1. clinically very good
  2. clinically good
  3. clinically sufficient
  4. clinically unsatisfactory
  5. clinically poor
18 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Assessment, Digital radiography
Time Frame: 18 month
Greyscale values ranged from 0 (black pixel) to 255 (white pixel).
18 month

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Pro. Heba Salah El Din Hamza (H.H.) Head of Conservative Dentistry Department, Cairo University., Professor, Professor, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.
  • Study Director: Dr. Rawda Hesham Abd ElAziz (R.H.) Lecturer of Conservative Dentistry Department,Cairo University, Lecturer, Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, 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)

June 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dentin Biomodification(G.S.E)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

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