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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-42
SponsorCairo University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to any of the restorative materials.

Patients undergoing orthodontic treatment with fixed appliances.

Pregnant women.

Patients with debilitating systemic diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 15% Grape seed extract as dentin pretreatment

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
18 month

Secondary outcomes

1

Radiographic Assessment, Digital radiography

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

Time frame
18 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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