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NCT Number: NCT06780527

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

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.

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Key information

Age range

22 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient-related criteria:
  • Adult patients (age: 22-42 years) of both genders.
  • Good oral hygiene.
  • Willing to sign the informed consent.
  • Co-operative patients who accept the follow-up period.
  • Tooth-related criteria:
  • Posterior permanent caries (ICDAS 5&6).
  • Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
  • Sensible teeth according to cold pulp test.
  • Negative response in percussion test.

Exclusion criteria

  • Patient-related criteria:
  • Allergy to any of the restorative materials.
  • Patients undergoing orthodontic treatment with fixed appliances.
  • Pregnant women.
  • Patients with debilitating systemic diseases.
  • Patient who frequently use analgesic or any drugs that could mask the pain.
  • Tooth-related criteria:
  • Teeth with previous restorations.
  • Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.
  • Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Chipped teeth or Cuspal loss

Treatment and study plan

15% Grape seed extract as dentin pretreatment

Other

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.

Primary outcomes

  1. 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

    • clinically very good
    • clinically good
    • clinically sufficient
    • clinically unsatisfactory
    • clinically poor

Secondary outcomes

  1. Radiographic Assessment, Digital radiography

    Time frame: 18 month

    Greyscale values ranged from 0 (black pixel) to 255 (white pixel).

Study contacts

Contact information is provided by the study sponsor or research team.

Marwah Faker Mohammed Al-Emad (M.F.) Master's student, Master

CONTACT

[email protected]

(+2) 01116398243

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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"

Acronym: GSE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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