Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05255913

Collaborator

(none)

360

Enrollment

Location

Arms

10.1

Anticipated Duration (Months)

35.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after twelve months in arresting ECC lesions.

The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Drug: Nanosilver Drug: Silver diamine fluoride	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1	Drug: Nanosilver preventive material for arresting caries
Active Comparator: group 2	Drug: Silver diamine fluoride preventive material for arresting caries

Arm

Intervention/Treatment

Experimental: group 1

Drug: Nanosilver

preventive material for arresting caries

Active Comparator: group 2

Drug: Silver diamine fluoride

preventive material for arresting caries

Outcome Measures

Primary Outcome Measures

caries arrest [1 year]
percentage of arresting caries in primary teeth

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children younger than 4 years old.
The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
Completion of an informed consent to participate in the study.

Exclusion Criteria:

Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.
Parental refusal to participate in the study.
Allergy or sensitivity to silver or any of the materials included in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maryam Quritum, dentist, Alexandria University

ClinicalTrials.gov Identifier:

NCT05255913

Other Study ID Numbers:

00010556-IORG:0008839

First Posted:

Feb 25, 2022

Last Update Posted:

Feb 25, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maryam Quritum, dentist, Alexandria University

Caries arrest, early childhood caries, Nanosilver fluoride

Additional relevant MeSH terms:

Fluorides

Study Results

No Results Posted as of Feb 25, 2022