Clinical trial NCT03554980: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Caries in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patient will receive either Silver Diamine Fluoride or Sodium Fluoride varnish according to the allocation ratio
Primary purpose: TREATMENT

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) .

Eligibility 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 12 months
Secondary outcomes:
measure: Parental satisfaction
timeFrame: 12 months
measure: Caries arrest (dentin texture) Cries arrest (Dentine texture)
timeFrame: 12 months
measure: Discoloration (yellow, brown, black)
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry, Faculty of Dentistry, Cairo University
Study officials:
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Nevine G Waly, Professor
role: STUDY_CHAIR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Eman S Elmasry, Professor
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Fatma KI Abdelgawad, Lecturer
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Marwa A Salmoon, MSc
role: PRINCIPAL_INVESTIGATOR
References: