A Phase 1 interventional study of Nano Care Gold and No intervention in Caries Class Ii, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 17 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-23.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration
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
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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).
Other: Nano Care Gold · Other: No intervention
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).
Other: No intervention · Other: Chlorhexidine
Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.
Also known as: Silver and Gold nano particles
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
Also known as: Negative control
2 % chlorhexidine gluconate. This group will be compared with no intervention group.
Also known as: chlorhexidine gluconate
Marginal adaptation
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
Time frame: 1 year
Marginal staining
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
Time frame: 1 year
Post operative sensitivity
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.
Time frame: 1 year
Plan to share: Undecided — Effect of Gold and Silver nano particles on marginal adaptation of resin composite
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Cairo University