Effect of Nano Care Gold on Marginal Integrity of Resin Composite

Phase 1

Completed

• Conditions: Caries Class Ii
• Interventions: Other: Nano Care Gold; Other: No intervention; Other: Chlorhexidine

• Registration Number: NCT03669224
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2019-11-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-19
• Study Completion: 2021-03-19
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano Care Gold	No intervention	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).
Nano Care Gold	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).
Chlorhexidine	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).
Chlorhexidine	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).

Primary Outcome Measures

Name	Time	Method
Marginal adaptation	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 Outcome Measures

Name	Time	Method
Marginal staining	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	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.

Trial Locations

Locations (1)

Aya Abd El-Fattah Mohammed Nemtallah; 🇪🇬 Maadi, Cairo, Egypt