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临床试验/NCT06780527
NCT06780527尚未招募不适用

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"

Cairo University0 个研究点目标入组 60 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Clinical Performance (Biological properties), Revised FDI criteria. (Clinically excellent-Success rate)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
22 Years 至 42 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Intervention group

Experimental

Application of resin composite restoration after partial caries removal with application of 15% GSE as dentin pretreatment.

干预措施: 15% Grape seed extract as dentin pretreatment (Other)

Control group

No Intervention

Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier.

结局指标

主要结局

Clinical Performance (Biological properties), Revised FDI criteria. (Clinically excellent-Success rate)

时间窗: 18 month

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

次要结局

  • Radiographic Assessment, Digital radiography(18 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwah Faker Mohammed Al-Emad

Master's student

Cairo University

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