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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.
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:
Benefits of the research to the clinician:
According to AAPD, 2017 SDF is:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
|
| Group 2 | Active Comparator | 5% sodium fluoride varnish will be applied four times annually and patients will be followed up at 0,1,3,6,9 and 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver Diamine Fluoride | Drug | SDF will be applied with a brush. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parental satisfaction | Parental satisfaction will be assessed through questioning the parent. Binary (yes or no) | 12 months |
| Caries arrest (dentin texture) Cries arrest (Dentine texture) | Caries arrest will be assessed through tactile examination (hard or soft). Categorical |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa A Salmoon, MSc | Contact | 01016555055 | dr.marwasalmon@gmail.com | |
| Fatma KI Abdelgawad, Lecturer | Contact | 01006753265 | fatmadent@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dentistry, Faculty of Dentistry, Cairo University | Cairo | Egypt |
outcome results for both groups will be shared
to be determined later
to be determined later
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| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
| C094502 | Bifluorid 12 |
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patient will receive either Silver Diamine Fluoride or Sodium Fluoride varnish according to the allocation ratio
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Double (participant, Outcomes Assessor)
| Sodium Fluoride varnish | Drug | NaF will be applied with a brush |
|
|
| 12 months |
| Discoloration (yellow, brown, black) | Discoloration will be assessed through visual examination. Categorical | 12 months |
| Fatma KI Abdelgawad, Lecturer | Pediatric Dentistry, Faculty of Dentistry, Cairo University | Study Director |
| Marwa A Salmoon, MSc | Pediatric Dentistry, Faculty of Dentistry, Cairo University | Principal Investigator |