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
1 other identifier
interventional
57
1 country
1
Brief Summary
The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2021
CompletedMarch 23, 2021
March 1, 2021
1.4 years
September 7, 2018
March 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Marginal staining
1 year
Post operative sensitivity
1 year
Study Arms (2)
Nano Care Gold
EXPERIMENTALSilver 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
ACTIVE COMPARATOR2% 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).
Interventions
Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.
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
2 % chlorhexidine gluconate. This group will be compared with no intervention group.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Aya Abd El-Fattah Mohammed Nemtallah
Maadi, Cairo Governorate, 11742, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer of Conservative Dentistry
Study Record Dates
First Submitted
September 7, 2018
First Posted
September 13, 2018
Study Start
November 1, 2019
Primary Completion
March 19, 2021
Study Completion
March 19, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03