Official Title
Clinical Performance and Radiographic Assessment of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Vital Teeth With Deep Occlusal Carious Lesions. "18-M Randomized Clinical Trial"
Brief Summary

This study will evaluate the clinical and radiographic performance of resin compositerestoration after utilized a grape seed extract as dentin biomodification in vital teethwith deep occlusal carious lesions (ICDAS 5-6) after selective soft dentin removaltechnique.

Detailed Description

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.

Not yet recruiting
Deep Carious Lesions

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.

Eligibility Criteria

Inclusion Criteria:

- Patient-related 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:

- Patient-related 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

Eligibility Gender
All
Eligibility Age
Minimum: 22 Years ~ Maximum: 42 Years
Locations

Not Provided

Contacts

Marwah Faker Mohammed Al-Emad (M.F.) Master's student, Master
(+2) 01116398243
marwah.faker@dentistry.cu.edu.eg

Cairo University
NCT Number
Keywords
Deep caries, Partial caries removal, Grape seed extract,
MeSH Terms
Dental Caries
Grape Seed Extract