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Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth

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ClinicalTrials.gov Identifier: NCT03554980
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Marwa A Salmoon, MSc, Cairo University

Brief Summary:
The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

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

Detailed Description:

Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children

Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

Benefits of the research to the patient:

According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:

  • Safe.
  • Noninvasive.
  • Inexpensive.
  • Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.

Benefits of the research to the clinician:

According to AAPD, 2017 SDF is:

  • Easily performed.
  • A promising strategy to manage dental caries in very young children or those who have special needs.
  • Doesn't require cooperation from children during dental treatment.

It will improve patient confidence with the dentist

Explanation for choice of comparators:

The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patient will receive either Silver Diamine Fluoride or Sodium Fluoride varnish according to the allocation ratio
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double (participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (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 at 0,1,3,6, 9 and 12.

SDF is a 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 patients 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. Postoperative Pain [ Time Frame: 12 months ]
    Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)


Secondary Outcome Measures :
  1. Parental satisfaction [ Time Frame: 12 months ]
    Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)

  2. Caries arrest (dentin texture) Cries arrest (Dentine texture) [ Time Frame: 12 months ]
    Caries arrest will be assessed through tactile examination (hard or soft). Categorical

  3. Discoloration (yellow, brown, black) [ Time Frame: 12 months ]
    Discoloration will be assessed through visual examination. Categorical



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

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
  5. Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
  6. Known allergies or sensitivities to dental materials, including SDF
  7. Inability to return for recall visits
  8. Refusal of participation from the guardian or parents

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 ClinicalTrials.gov identifier (NCT number): NCT03554980


Contacts
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Contact: Marwa A Salmoon, MSc 01016555055 dr.marwasalmon@gmail.com
Contact: Fatma KI Abdelgawad, Lecturer 01006753265 fatmadent@hotmail.com

Locations
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Egypt
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: 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 Director: Fatma KI Abdelgawad, Lecturer Pediatric Dentistry, Faculty of Dentistry, Cairo University
Principal Investigator: Marwa A Salmoon, MSc Pediatric Dentistry, Faculty of Dentistry, Cairo University

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Responsible Party: Marwa A Salmoon, MSc, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03554980     History of Changes
Other Study ID Numbers: CEBD-CU-2018-06-1
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 14, 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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Fluorides
Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents