NCT04930458

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 31, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

May 31, 2021

Last Update Submit

May 16, 2022

Conditions

Keywords

Dental caries remineralizationNanosilver fluoride

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Nanosilver fluoride group

EXPERIMENTAL

Nanosilver fluoride will be applied on carious lesion

Other: Nanosilver fluoride

Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group

ACTIVE COMPARATOR

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 varnish group

ACTIVE COMPARATOR

Sodium fluoride varnish will be applied on carios lesion

Other: Sodium fluoride varnish

Interventions

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

Nanosilver fluoride group

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 with casein phosphopeptides_Amorphous calcium phosphate group

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

Sodium fluoride varnish group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alhur alriyahi specialized dental center

Karbala, Iraq

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium FluorideBifluorid 12

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Duaa Jawad

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist.. master student

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 18, 2021

Study Start

August 10, 2021

Primary Completion

September 20, 2021

Study Completion

June 20, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations