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

NCT06780527 | Not Yet Recruiting DMC

• 1 other identifier: Dentin Biomodification(G.S.E)
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Deep Carious Lesions

Keywords

Deep caries, Partial caries removal, Grape seed extract,

Outcome Measures

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

  18 month

Secondary Outcomes (1)

• Radiographic Assessment, Digital radiography

  18 month

Study Arms (2)

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.

Other: 15% Grape seed extract as dentin pretreatment

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 22 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (8)

• 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.

  PMID: 38962594 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.

  PMID: 36504246 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.

  PMID: 36460919 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.

  PMID: 35704241 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.

  PMID: 21167964 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.

  PMID: 29176304 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.

  PMID: 36013786 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.

  PMID: 38584280 RESULT

MeSH Terms

Interventions

Grape Seed Extract

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• 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

  Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

(+2) 01116398243; marwah.faker@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's student

Model Details: Two parallel arms randomized clinical trial with equal allocation ratio.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share