Discoloration of Carious Primary Teeth After Application... | NCT03557996

Studies
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

NCT03557996

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 18, 2018Actual

Enrollment

42Estimated

Phase

Phase 4

Conditions

Dental Caries in Children

Interventions

Silver Diamine Fluoride
Sodium Fluoride Varnish

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Estimated

Primary Completion Date

Nov 1, 2019Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Jun 5, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2018

Last Update Posted Date

Jun 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yousra Mohamed, Principal investigator, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

Detailed Description

The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.

Benefit to the patient

No pain and infection.
Enhance child cooperation.
Enhance better patient compliance.
Decrease cost of dental treatment and may eliminate the need for General Anesthesia.

Benefit to the dentist

Develop an effective fast easy method to arrest the caries by using SDF.
Ease of dental treatment.
Better cooperation with the child.
The procedure is simple.
Inexpensive and non-invasive.
It does not require expensive equipment or support infrastructure, such as pipe water or electricity.

Benefit to the population

Reduce the harmful impact of oral health problems in preschool children from low income families.
SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.

Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid	Drug: Silver Diamine Fluoride
Group 2	Active Comparator	5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12	Drug: Sodium Fluoride Varnish

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silver Diamine Fluoride	Drug	SDF will be applied with a brush	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Discoloration	Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Investigator reported discoloration	Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination	12 months
Timing of discoloration	Visual examination at follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with carious primary teeth before eruption of permanent teeth
High caries risk patients with anterior or posterior carious lesions
Uncooperative children without access to or with difficulty accessing dental care.

Exclusion Criteria:

Children with spontaneous or elicited pain from caries
Tooth mobility
Signs of pulpal infection
Severe medical conditions that would not allow management in the clinic

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yousra M Abdel Rehim, MSc	Contact	01273335144		yousra.mohamed@dentistry.cu.edu.eg
Fatma KI Abdelgawad, Lecturer	Contact	01006753265		fatmadent@hotmail.com

Overall Officials

Name	Affiliation	Role
Nevine G Waly, Professor	Pediatric Dentistry,Faculty of Dentistry, Cairo University	Study Director
Eman S Elmasry, Professor	Pediatric Dentistry, Faculty of Dentistry, Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Dentistry, Faculty of Dentistry, Cairo University		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

outcome results for both groups will be shared

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

to be determined later

Access Criteria

to be determined later

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C024633	silver diamine fluoride
C094502	Bifluorid 12

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided