NCT04213573

Brief Summary

This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

December 18, 2019

Last Update Submit

March 24, 2020

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • caries arrestment

    The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe

    2 weeks

Secondary Outcomes (1)

  • Parent perception

    0 - 2 weeks

Study Arms (2)

Group 1: topical application of silver diamine fluoride

EXPERIMENTAL

38% silver diamine fluoride liquid

Drug: silver diamine fluoride

Group 2: topical application of MI varnish.

ACTIVE COMPARATOR

MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate

Drug: MI Varnish

Interventions

silver diamine fluorideDRUG

38% silver diamine fluoride liquid will be applied with a brush

Also known as: SDF
Group 1: topical application of silver diamine fluoride
MI VarnishDRUG

topical fluoride varnish with calcium and phosphate

Group 2: topical application of MI varnish.

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Normal healthy children without any systemic disease ASA 1 physical status.
  • Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)

You may not qualify if:

  • Children who suffer from major systemic diseases and require long term medications.
  • Children refuse the study intervention.
  • Children with silver or milk product sensitivity.
  • Presence of any gingival or perioral ulceration or stomatitis.
  • Tooth with abscess, fistula or severe pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

al-Ameriya dental specialized center

Baghdad, Al-karkh, 10, Iraq

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 30, 2019

Study Start

January 21, 2020

Primary Completion

October 20, 2020

Study Completion

December 20, 2020

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

IR(1)