KiruPoderoso: Silver Diamine Fluoride Gel: Case Series

• Sponsor: Advantage Silver Dental Arrest, LLC (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05395065
• Collaborator: Universidad Nacional Del Altiplano Puno (Other), University of Washington (Other)
• Enrollment: 235
• Locations: 5
• Anticipated Duration (Months): 17.7
• Patients Per Site: 47
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Device: Silver Diamine Fluoride/Sodium Fluoride Varnish

Detailed Description

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Study Design

• Study Type: Observational
• Actual Enrollment: 235 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series
• Actual Study Start Date: Jul 11, 2022
• Anticipated Primary Completion Date: Jul 16, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
SDF/FV Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months	Device: Silver Diamine Fluoride/Sodium Fluoride Varnish; Application of dental caries arresting topical medication; Other Names: Advantage Silver Dental Arrest 38% Gel Fluorimax 2.5% Sodium Fluoride Varnish

Outcome Measures

Primary Outcome Measures

1. Lesion Activity [5 months]

   Caries Lesion Arrest

2. Lesion Activity [12 months]

   Caries Lesion Arrest

Secondary Outcome Measures

1. Caries Increment [5 months]

   Caries Increment (d2-4mfs)

2. Caries Increment [12 months]

   Caries Increment (d2-4mfs)

3. New Caries Lesions [5 months]

   Rate of New Caries Lesions ((d2-4mfs)

4. New Caries Lesions [12 months]

   Rate of New Caries Lesions ((d2-4mfs)

5. Satisfaction with Color Changes in Teeth [5 months]

   Bothered by Color Changes in the teeth (1-10 scale)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 4 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• At least one active caries lesion Good general health by parent report

Exclusion Criteria:

• Unable to cooperate with exam or procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UGEL Manazo	Puno		Peru
2	UGEL Puno 210001 Las Torres	Puno		Peru
3	UGEL Puno Magisterial	Puno		Peru
4	UGEL San Jose	Puno		Peru
5	UGEL Villa del Lago	Puno		Peru

Sponsors and Collaborators

• Advantage Silver Dental Arrest, LLC
• Universidad Nacional Del Altiplano Puno
• University of Washington

Investigators

• Principal Investigator: Taina Padilla Caceres, DDS, Universidad Nacional del Altiplano

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70.
• Kiesow A, Menzel M, Lippert F, Tanzer JM, Milgrom P. Dentin tubule occlusion by a 38% silver diamine fluoride gel: an in vitro investigation. BDJ Open. 2022 Jan 13;8(1):1. doi: 10.1038/s41405-022-00095-8.

• Responsible Party: Advantage Silver Dental Arrest, LLC
• ClinicalTrials.gov Identifier: NCT05395065
• Other Study ID Numbers: Gel 2022-1
• First Posted: May 27, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Advantage Silver Dental Arrest, LLC: Silver Diamine Fluoride; Sodium Fluoride Varnish; Dental Caries; Primary Dentition; Peru
• Additional relevant MeSH terms: Dental Caries; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical

Study Results

No Results Posted as of Aug 12, 2022