Effect of Nano Care Gold on Marginal Integrity of Resin Composite

NCT ID: NCT03669224

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-03-19

Brief Summary

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

Detailed Description

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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

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Caries Class Ii

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Nano Care Gold

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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 solution will be applied to prepared cavity followed by adhesive system then resin composite. This arm will be compared with no intervention (negative control).

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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Nano Care Gold

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

Intervention Type OTHER

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

Intervention Type OTHER

Chlorhexidine

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

Intervention Type OTHER

Other Intervention Names

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Silver and Gold nano particles Negative control chlorhexidine gluconate

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Aya Abd El-Fattah Mohammed

Assistant Lecturer of Conservative Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aya Abd El-Fattah Mohammed Nemtallah

Maadi, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2018-09-04

Identifier Type: -

Identifier Source: org_study_id

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