Effect of Nano Care Gold on Marginal Integrity of Resin Composite

Overview

The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration

Full Title of Study: “Marginal Integrity of Resin Composite Restoration With & Without Surface Pretreatment by Gold & Silver Nanoparticles Versus Chlorhexidine in Class II Cavities Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 19, 2021

Detailed Description

This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both materials will be used as a surface pre-treatment. Their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. The follow up period is one year

Interventions

  • Other: Nano Care Gold
    • Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.
  • Other: No intervention
    • No intervention will be applied in this group. It will be the negative comparator. In this group only the standard of care will be applied, which means the steps will be cavity preparation followed by adhesive system then resin composite without any surface pre-treatment
  • Other: Chlorhexidine
    • 2 % chlorhexidine gluconate. This group will be compared with no intervention group.

Arms, Groups and Cohorts

  • Experimental: Nano Care Gold
    • Silver and Gold nano particles suspended in 70 % isopropyl alcohol. It will be used for cavity pre-treatment. This arm will be compared with no intervention (negative control).
  • Active Comparator: Chlorhexidine
    • 2% chlorhexidine gluconate solution will be applied to prepared cavity followed by adhesive system then resin composite. This arm will be compared with no intervention (negative control).

Clinical Trial Outcome Measures

Primary Measures

  • Marginal adaptation
    • Time Frame: 1 year
    • It will be measured by FDI probe and Digora x-ray machine. FDI Scoring system (categorical) 5 steps(3 accepted, 2 unaccepted) will be used to evaluate the outcome of measuring device

Secondary Measures

  • Marginal staining
    • Time Frame: 1 year
    • Visual inspection and Photographs will be used to measure the outcome. FDI Scoring system(categorical) 5 steps(3 accepted, 2 unaccepted) will be used to evaluate the outcome
  • Post operative sensitivity
    • Time Frame: 1 year
    • A blast of cold air will be used to evaluate the restoration. FDI Scoring system(categorical) 5 steps(3 accepted, 2 unaccepted) will be used to determine the restoration fit in which category.

Participating in This Clinical Trial

Inclusion Criteria

  • (1) Patients with at least two class II cavities (2) 17-50 years old (3) Males or females (4) Good or hygiene (5) Good general health (6) Cooperative patients (7) Subjects who signed the informed consent Exclusion Criteria:

1. Patients younger than 17 years or older than 50 years old 2. Pregnant females 3. Disabilities 4. Systemic disease or severe medical complications 5. Heavy smoking 6. Lack of compliance

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aya Abd El-Fattah Mohammed, Assistant Lecturer of Conservative Dentistry – Cairo University

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