Caries Class IiPhase 1NCT03669224
Effect of Nano Care Gold on Marginal Integrity of Resin Composite
A Phase 1 study testing Nano Care Gold and Chlorhexidine in people with Caries Class Ii, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration Read more about this study
- Who is it for?
- Ages 17 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Class Ii
- What is being tested?
- Nano Care Gold and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 19 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aya Abd El-Fattah Mohammed Nemtallah
Maadi, Cairo Governorate, 11742
About this study
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
The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration
Read the 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
- Conditions
- Caries Class Ii
- Being tested
- Nano Care Gold, No intervention, Chlorhexidine
- Keywords
- marginal adptation, marginal staining, post operative sensitivity, recurrent caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Care GoldOther
Also called Silver and Gold nano particles
Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.
No interventionOther
Also called Negative control
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
ChlorhexidineOther
Also called chlorhexidine gluconate
2 % chlorhexidine gluconate. This group will be compared with no intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Nano Care Gold | Experimental | 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). Receives: Other: Nano Care Gold; Other: No intervention |
| Chlorhexidine | Active comparator | 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). Receives: Other: No intervention; Other: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Nov 2019
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries Class IiStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abd El-Fattah Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669224
- Sponsor's protocol ID
- CEBD-CU-2018-09-04
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Effect of Gold and Silver nano particles on marginal adaptation of resin composite
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03669224
- Acronym / sponsor ID
- CEBD-CU-2018-09-04
- Conditions
- Caries Class Ii
- Keywords
- marginal adptation, marginal staining, post operative sensitivity, recurrent caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano Care Gold | Experimental | Other: Nano Care Gold, Other: No interventionSilver 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 comparator | Other: No intervention, Other: Chlorhexidine2% 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). |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (6 listed)
- Patients younger than 17 years or older than 50 years old
- Pregnant females
- Disabilities
- Systemic disease or severe medical complications
- Heavy smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano Care GoldAlso: Silver and Gold nano particlesMixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group. | Other | Nano Care Gold |
| No interventionAlso: Negative controlNo 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 | Other | Chlorhexidine, Nano Care Gold |
| ChlorhexidineAlso: chlorhexidine gluconate2 % chlorhexidine gluconate. This group will be compared with no intervention group. | Other | Chlorhexidine |
Primary outcome
Marginal adaptation
Time frame: 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
2 secondary outcomes
Marginal staining
Time frame: 1 year
Post operative sensitivity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Undecided. Effect of Gold and Silver nano particles on marginal adaptation of resin composite
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nano Care Gold and Chlorhexidine in people with Caries Class Ii, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.