Clinical Performance of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Deep Carious Lesions.
NCT ID: NCT06780527
Last Updated: 2025-01-17
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-06-01
2027-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier.
No interventions assigned to this group
Intervention group
Application of resin composite restoration after partial caries removal with application of 15% GSE as dentin pretreatment.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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
22 Years
42 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Marwah Faker Mohammed Al-Emad
Master's student
Principal Investigators
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Pro. Heba Salah El Din Hamza (H.H.) Head of Conservative Dentistry Department, Cairo University., Professor
Role: STUDY_DIRECTOR
Professor, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.
Dr. Rawda Hesham Abd ElAziz (R.H.) Lecturer of Conservative Dentistry Department,Cairo University, Lecturer
Role: STUDY_DIRECTOR
Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.
Central Contacts
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Marwah Faker Mohammed Al-Emad (M.F.) Master's student, Master
Role: CONTACT
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Dentin Biomodification(G.S.E)
Identifier Type: -
Identifier Source: org_study_id
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