Effect of Nano Care Gold on Marginal Integrity of Resin Composite

Caries Class Ii Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669224
• Other study ID #: CEBD-CU-2018-09-04
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2019
• Est. completion date: March 19, 2021

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries Class Ii

Intervention

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

Locations

Country	Name	City	State
Egypt	Aya Abd El-Fattah Mohammed Nemtallah	Maadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1 year
Secondary	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.	1 year