An interventional study of 15% Grape seed extract as dentin pretreatment in Deep Carious Lesions, sponsored by Cairo University. Not yet recruiting. Open to participants aged 22 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Patient-related criteria:
Tooth-related criteria:
Exclusion Criteria:
Patient-related criteria:
Tooth-related criteria:
Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier.
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.
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
Radiographic Assessment, Digital radiography
Greyscale values ranged from 0 (black pixel) to 255 (white pixel).
Time frame: 18 month
No study locations are listed for this record.
Plan to share: Yes
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Cairo University