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

June 14, 2018 updated by: Yousra Mohamed, Cairo University

Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Pediatric Dentistry, Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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
SDF will be applied with a brush
Other Names:
  • SDF
Active Comparator: Group 2
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
NaF will be applied with a brush
Other Names:
  • NaF varnish

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator reported discoloration
Time Frame: 12 months
Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
12 months
Timing of discoloration
Time Frame: 12 months
Visual examination at follow up
12 months
Caries arrest (dentine texture)
Time Frame: 12 months
Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
12 months
Postoperative Pain: Questioning the patient
Time Frame: 12 months
Questioning the patient and/or the parentBinary (yes or No)
12 months
Parental satisfaction: Questioning the parent
Time Frame: 12 months
Questioning the parent
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Fatma KI Abdelgawad, Lecturer, Pediatric Dentistry, Faculty of Dentistry, Cairo University
  • Study Director: Nevine G Waly, Professor, Pediatric Dentistry,Faculty of Dentistry, Cairo University
  • Study Chair: Eman S Elmasry, Professor, Pediatric Dentistry, Faculty of Dentistry, Cairo University
  • Principal Investigator: Yousra M Abdel Rehim, MSc, Pediatric Dentistry, Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-06-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

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

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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