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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier. | |
| Intervention group | Experimental | Application of resin composite restoration after partial caries removal with application of 15% GSE as dentin pretreatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance (Biological properties), Revised FDI criteria. (Clinically excellent-Success rate) | Postoperative hypersensitivity and pulpal status/ Caries at restoration margins (CAR), Scores
| 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Assessment, Digital radiography | Greyscale values ranged from 0 (black pixel) to 255 (white pixel). | 18 month |
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Inclusion Criteria:
Patient-related criteria:
Tooth-related criteria:
Exclusion Criteria:
Patient-related criteria:
Tooth-related criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwah Faker Mohammed Al-Emad (M.F.) Master's student, Master | Contact | (+2) 01116398243 | marwah.faker@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38962594 | Result | Kls N, Ramar K. Evaluation of the Genotoxic Effects of Grape Seed Extract and Marine Collagen Peptide on the Fibroblast Cell Line: An In Vitro Study. Cureus. 2024 Jun 3;16(6):e61605. doi: 10.7759/cureus.61605. eCollection 2024 Jun. | |
| 36504246 | Result | Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12. |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Two parallel arms randomized clinical trial with equal allocation ratio.
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|
| Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt. |
| Study Director |
| 36460919 | Result | Gozetici-Cil B, Erdem-Hepsenoglu Y, Tekin A, Ozcan M. Selective removal to soft dentine or selective removal to firm dentine for deep caries lesions in permanent posterior teeth: a randomized controlled clinical trial up to 2 years. Clin Oral Investig. 2023 May;27(5):2125-2137. doi: 10.1007/s00784-022-04815-0. Epub 2022 Dec 3. |
| 35704241 | Result | Cushley S, Duncan HF, Lundy FT, Nagendrababu V, Clarke M, El Karim I. Outcomes reporting in systematic reviews on vital pulp treatment: A scoping review for the development of a core outcome set. Int Endod J. 2022 Sep;55(9):891-909. doi: 10.1111/iej.13785. Epub 2022 Jun 30. |
| 21167964 | Result | Bedran-Russo AK, Castellan CS, Shinohara MS, Hassan L, Antunes A. Characterization of biomodified dentin matrices for potential preventive and reparative therapies. Acta Biomater. 2011 Apr;7(4):1735-41. doi: 10.1016/j.actbio.2010.12.013. Epub 2010 Dec 16. |
| 29176304 | Result | Balalaie A, Rezvani MB, Mohammadi Basir M. Dual function of proanthocyanidins as both MMP inhibitor and crosslinker in dentin biomodification: A literature review. Dent Mater J. 2018 Mar 30;37(2):173-182. doi: 10.4012/dmj.2017-062. Epub 2017 Nov 23. |
| 36013786 | Result | Anumula L, Ramesh S, Kolaparthi VSK, Kirubakaran R, Karobari MI, Arora S, Saleh AA, Aldowah O, Messina P, Scardina GA. Role of Natural Cross Linkers in Resin-Dentin Bond Durability: A Systematic Review and Meta-Analysis. Materials (Basel). 2022 Aug 17;15(16):5650. doi: 10.3390/ma15165650. |
| 38584280 | Result | Abd ElAziz RH, Ragab RA, Elzayat GA. Comparative evaluation and patient satisfaction with an electrical impedance-based device versus digital radiography in the estimation of remaining dentin thickness in carious posterior permanent teeth: (Diagnostic accuracy study). BMC Oral Health. 2024 Apr 8;24(1):429. doi: 10.1186/s12903-024-04205-w. |
| D004364 |
| Pharmaceutical Preparations |