Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
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
About this trial
This is an interventional treatment trial for Dental Caries in Children
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
- Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
- Known allergies or sensitivities to dental materials, including SDF
- Inability to return for recall visits
- Refusal of participation from the guardian or parents
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 at 0,1,3,6, 9 and 12. SDF is a brush-on liquid.
5% sodium fluoride varnish will be applied four times annually and patients will be followed up at 0,1,3,6,9 and 12.
Outcomes
Primary Outcome Measures
Postoperative Pain
Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)
Secondary Outcome Measures
Parental satisfaction
Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)
Caries arrest (dentin texture) Cries arrest (Dentine texture)
Caries arrest will be assessed through tactile examination (hard or soft). Categorical
Discoloration (yellow, brown, black)
Discoloration will be assessed through visual examination. Categorical
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03554980
Brief Title
Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
Official Title
Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (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
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.
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) .
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 according to the allocation ratio
Masking
ParticipantOutcomes Assessor
Masking Description
Double (participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
46 (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 at 0,1,3,6, 9 and 12.
SDF is a brush-on liquid.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
5% sodium fluoride varnish will be applied four times annually and patients 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
Postoperative Pain
Description
Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Parental satisfaction
Description
Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)
Time Frame
12 months
Title
Caries arrest (dentin texture) Cries arrest (Dentine texture)
Description
Caries arrest will be assessed through tactile examination (hard or soft). Categorical
Time Frame
12 months
Title
Discoloration (yellow, brown, black)
Description
Discoloration will be assessed through visual examination. Categorical
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
Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
Known allergies or sensitivities to dental materials, including SDF
Inability to return for recall visits
Refusal of participation from the guardian or parents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa A Salmoon, MSc
Phone
01016555055
Email
dr.marwasalmon@gmail.com
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 Chair
First Name & Middle Initial & Last Name & Degree
Eman S Elmasry, Professor
Organizational Affiliation
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Official's Role
Study Director
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
Marwa A Salmoon, 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
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
Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
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