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Effect of Nano Care Gold on Marginal Integrity of Resin Composite

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03669224
Enrollment
57
Registered
2018-09-13
Start date
2019-11-01
Completion date
2021-03-19
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Class Ii

Keywords

marginal adptation, marginal staining, post operative sensitivity, recurrent caries

Brief summary

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

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

OTHERNano Care Gold

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

OTHERNo 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

OTHERChlorhexidine

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal adaptation1 yearIt 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

MeasureTime frameDescription
Marginal staining1 yearVisual 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 sensitivity1 yearA 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026