NCT03554980

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

Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Accepted

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) .

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
DRUG	Silver Diamine Fluoride	SDF will be applied with a brush.
DRUG	Sodium Fluoride varnish	NaF will be applied with a brush

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-11-01
• Completion: 2020-06-01
• First posted: 2018-06-13
• Last updated: 2018-06-14

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study