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Completed

NCT Number: NCT03669224

Effect of Nano Care Gold on Marginal Integrity of Resin Composite

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

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Key information

Conditions

Caries Class II

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aya Abd El-Fattah Mohammed Nemtallah

Maadi, Cairo Governorate, 11742, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Patients younger than 17 years or older than 50 years old
  • Pregnant females
  • Disabilities
  • Systemic disease or severe medical complications
  • Heavy smoking
  • Lack of compliance

Treatment and study plan

Nano Care Gold

Other

Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.

Other names: Silver and Gold nano particles

No intervention

Other

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 names: Negative control

Chlorhexidine

Other

2 % chlorhexidine gluconate. This group will be compared with no intervention group.

Other names: chlorhexidine gluconate

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2018
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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