Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate

NCT ID: NCT04930458

Last Updated: 2022-05-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2022-06-20

Brief Summary

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The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides\_amorphous calcium phosphate in the remineralization of dental caries.

Detailed Description

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the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides\_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Nanosilver fluoride group

Nanosilver fluoride will be applied on carious lesion

Group Type EXPERIMENTAL

Nanosilver fluoride

Intervention Type OTHER

Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months

Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group

Sodium fluoride with casein phosphopeptides\_Amorphous calcium phosphate will be applied on carios lesion

Group Type ACTIVE_COMPARATOR

Sodium fluoride with casein phosphopeptides amorphous calcium phosphate

Intervention Type OTHER

Sodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months

Sodium fluoride varnish group

Sodium fluoride varnish will be applied on carios lesion

Group Type ACTIVE_COMPARATOR

Sodium fluoride varnish

Intervention Type OTHER

Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months

Interventions

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Nanosilver fluoride

Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months

Intervention Type OTHER

Sodium fluoride with casein phosphopeptides amorphous calcium phosphate

Sodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months

Intervention Type OTHER

Sodium fluoride varnish

Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.
* The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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duaa jawad

Dentist.. master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duaa Jawad

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

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Alhur alriyahi specialized dental center

Karbala, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Duaa Jawad

Role: CONTACT

07707535959

Aseel Haider

Role: CONTACT

07901810659

Facility Contacts

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Duaa Jawad

Role: primary

07707535959

Aseel Haider

Role: backup

07901810659

Other Identifiers

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Dentine caries remineralizatio

Identifier Type: -

Identifier Source: org_study_id

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