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NCT04930458 Clinical Trial

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

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04930458
Other study ID # Dentine caries remineralizatio
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 10, 2021
Est. completion date June 20, 2022

Study information
Verified date May 2022
Source University of Baghdad
Contact Duaa Jawad
Phone 07707535959
Email duaajawad1@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 135
Est. completion date June 20, 2022
Est. primary completion date September 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility - 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iraq Alhur alriyahi specialized dental center Karbala

Sponsors (1)
Lead Sponsor Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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
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