Back to resultsRemineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
Primary Purpose
Dental Caries
Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Nanosilver fluoride
Sodium fluoride with casein phosphopeptides amorphous calcium phosphate
Sodium fluoride varnish
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dental caries remineralization, Nanosilver fluoride
Eligibility Criteria
- 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
Sites / Locations
- Alhur alriyahi specialized dental centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Nanosilver fluoride group
Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group
Sodium fluoride varnish group
Arm Description
Nanosilver fluoride will be applied on carious lesion
Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate will be applied on carios lesion
Sodium fluoride varnish will be applied on carios lesion
Outcomes
Primary Outcome Measures
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930458
Brief Title
Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
Official Title
Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
June 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries remineralization, Nanosilver fluoride
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nanosilver fluoride group
Arm Type
Experimental
Arm Description
Nanosilver fluoride will be applied on carious lesion
Arm Title
Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group
Arm Type
Active Comparator
Arm Description
Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate will be applied on carios lesion
Arm Title
Sodium fluoride varnish group
Arm Type
Active Comparator
Arm Description
Sodium fluoride varnish will be applied on carios lesion
Intervention Type
Other
Intervention Name(s)
Nanosilver fluoride
Intervention Description
Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months
Intervention Type
Other
Intervention Name(s)
Sodium fluoride with casein phosphopeptides amorphous calcium phosphate
Intervention Description
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
Intervention Name(s)
Sodium fluoride varnish
Intervention Description
Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months
Primary Outcome Measure Information:
Title
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duaa Jawad
Phone
07707535959
Email
duaajawad1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aseel Haider
Phone
07901810659
Email
dr.aseelhaider@codental.uobaghdad.edu.iq
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duaa Jawad
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alhur alriyahi specialized dental center
City
Karbala
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duaa Jawad
Phone
07707535959
Email
Duaajawad1@gmail.com
First Name & Middle Initial & Last Name & Degree
Aseel Haider
Phone
07901810659
Email
dr.aseelhaider@codental.uobaghdad.edu.iq
12. IPD Sharing Statement
Learn more about this trial
Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
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