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

• Sponsor: University of Baghdad (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04930458
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10.3
• Patients Per Site Per Month: 13.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Nanosilver fluoride; Other: Sodium fluoride with casein phosphopeptides amorphous calcium phosphate; Other: Sodium fluoride varnish	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)
• Actual Study Start Date: Aug 10, 2021
• Actual Primary Completion Date: Sep 20, 2021
• Anticipated Study Completion Date: Jun 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alhur alriyahi specialized dental center	Karbala		Iraq

Sponsors and Collaborators

• University of Baghdad

Investigators

• Principal Investigator: Duaa Jawad, University of Baghdad

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: duaa jawad, Dentist.. master student, University of Baghdad
• ClinicalTrials.gov Identifier: NCT04930458
• Other Study ID Numbers: Dentine caries remineralizatio
• First Posted: Jun 18, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by duaa jawad, Dentist.. master student, University of Baghdad: Dental caries remineralization; Nanosilver fluoride
• Additional relevant MeSH terms: Dental Caries; Listerine; Calcium; Fluorides; Sodium Fluoride; Fluorides, Topical; Caseins

Study Results

No Results Posted as of May 17, 2022