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

Primary Purpose

Dental Caries in Children

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Silver Diamine Fluoride
Sodium Fluoride Varnish
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

1 Year - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Pediatric Dentistry, Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12

Outcomes

Primary Outcome Measures

Discoloration
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)

Secondary Outcome Measures

Investigator reported discoloration
Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
Timing of discoloration
Visual examination at follow up
Caries arrest (dentine texture)
Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
Postoperative Pain: Questioning the patient
Questioning the patient and/or the parentBinary (yes or No)
Parental satisfaction: Questioning the parent
Questioning the parent

Full Information

First Posted
June 5, 2018
Last Updated
June 14, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03557996
Brief Title
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish
Official Title
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
patient will receive either silver diamine fluoride or sodium fluoride varnish
Masking
ParticipantOutcomes Assessor
Masking Description
double (participant-outcome assessor)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12
Intervention Type
Drug
Intervention Name(s)
Silver Diamine Fluoride
Other Intervention Name(s)
SDF
Intervention Description
SDF will be applied with a brush
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride Varnish
Other Intervention Name(s)
NaF varnish
Intervention Description
NaF will be applied with a brush
Primary Outcome Measure Information:
Title
Discoloration
Description
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Investigator reported discoloration
Description
Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
Time Frame
12 months
Title
Timing of discoloration
Description
Visual examination at follow up
Time Frame
12 months
Title
Caries arrest (dentine texture)
Description
Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
Time Frame
12 months
Title
Postoperative Pain: Questioning the patient
Description
Questioning the patient and/or the parentBinary (yes or No)
Time Frame
12 months
Title
Parental satisfaction: Questioning the parent
Description
Questioning the parent
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousra M Abdel Rehim, MSc
Phone
01273335144
Email
yousra.mohamed@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma KI Abdelgawad, Lecturer
Phone
01006753265
Email
fatmadent@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine G Waly, Professor
Organizational Affiliation
Pediatric Dentistry,Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eman S Elmasry, Professor
Organizational Affiliation
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatma KI Abdelgawad, Lecturer
Organizational Affiliation
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yousra M Abdel Rehim, MSc
Organizational Affiliation
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Dentistry, Faculty of Dentistry, Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatma KI Abdelgawad, Lecturer
Phone
01006753265
Email
fatmadent@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yousra M Abdel Rehim, MSc
First Name & Middle Initial & Last Name & Degree
Fatma KI Abdelgawad, Lecturer
First Name & Middle Initial & Last Name & Degree
Nevine G Waly, Professor
First Name & Middle Initial & Last Name & Degree
Eman S Elmasry, Professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
outcome results for both groups will be shared
IPD Sharing Time Frame
to be determined later
IPD Sharing Access Criteria
to be determined later

Learn more about this trial

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

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