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Trial record 13 of 292 for:    Sodium Fluoride OR Duraphat

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03557996
Recruitment Status : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Information provided by (Responsible Party):
Yousra Mohamed, Cairo University

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

Condition or disease Intervention/treatment Phase
Dental Caries in Children Drug: Silver Diamine Fluoride Drug: Sodium Fluoride Varnish Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patient will receive either silver diamine fluoride or sodium fluoride varnish
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double (participant-outcome assessor)
Primary Purpose: Treatment
Official Title: Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

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 Name: 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 Name: NaF varnish

Primary Outcome Measures :
  1. Discoloration [ Time Frame: 12 months ]
    Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)

Secondary Outcome Measures :
  1. Investigator reported discoloration [ Time Frame: 12 months ]
    Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination

  2. Timing of discoloration [ Time Frame: 12 months ]
    Visual examination at follow up

  3. Caries arrest (dentine texture) [ Time Frame: 12 months ]
    Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination

  4. Postoperative Pain: Questioning the patient [ Time Frame: 12 months ]
    Questioning the patient and/or the parentBinary (yes or No)

  5. Parental satisfaction: Questioning the parent [ Time Frame: 12 months ]
    Questioning the parent

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03557996

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Contact: Yousra M Abdel Rehim, MSc 01273335144
Contact: Fatma KI Abdelgawad, Lecturer 01006753265

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Pediatric Dentistry, Faculty of Dentistry, Cairo University Not yet recruiting
Cairo, Egypt
Contact: Fatma KI Abdelgawad, Lecturer    01006753265   
Principal Investigator: Yousra M Abdel Rehim, MSc         
Sub-Investigator: Fatma KI Abdelgawad, Lecturer         
Sub-Investigator: Nevine G Waly, Professor         
Sub-Investigator: Eman S Elmasry, Professor         
Sponsors and Collaborators
Cairo University
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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
Study Director: Fatma KI Abdelgawad, Lecturer Pediatric Dentistry, Faculty of Dentistry, Cairo University
Principal Investigator: Yousra M Abdel Rehim, MSc Pediatric Dentistry, Faculty of Dentistry, Cairo University

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Responsible Party: Yousra Mohamed, Principal investigator, Cairo University Identifier: NCT03557996     History of Changes
Other Study ID Numbers: CEBD-CU-2018-06-2
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: outcome results for both groups will be shared
Supporting Materials: 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

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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
Additional relevant MeSH terms:
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Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents