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

Not Applicable

Not yet recruiting

• Conditions: Deep Carious Lesions

• Registration Number: NCT06780527
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-06-01
• Primary Completion: 2026-12-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Performance (Biological properties), Revised FDI criteria. (Clinically excellent-Success rate)	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

Secondary Outcome Measures

Name	Time	Method
Radiographic Assessment, Digital radiography	18 month	Greyscale values ranged from 0 (black pixel) to 255 (white pixel).