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

May 16, 2022 updated by: duaa jawad, University of Baghdad

Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • Clinical diagnosis of carious lesion
  • participants should be free of any systemic diseases.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanosilver fluoride group
Nanosilver fluoride will be applied on carious lesion
Other: Nanosilver fluoride
Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months
Active Comparator: Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group
Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate will be applied on carios lesion
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
Active Comparator: Sodium fluoride varnish group
Sodium fluoride varnish will be applied on carios lesion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
Time Frame: Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by blunt probe.
Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Duaa Jawad, University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

September 20, 2021

Study Completion (Anticipated)

June 20, 2022

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dentine caries remineralizatio

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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