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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Dental Caries in Children

Treatments

Drug: Silver Diamine Fluoride
Drug: Sodium Fluoride varnish

Study type

Interventional

Funder types

Other

Identifiers

NCT03554980
CEBD-CU-2018-06-1

Details and patient eligibility

About

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.

Full 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) .

Enrollment

46 estimated patients

Sex

All

Ages

1 to 6 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups

Group 1
Experimental group
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.
Treatment:
Drug: Silver Diamine Fluoride
Group 2
Active Comparator group
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.
Treatment:
Drug: Sodium Fluoride varnish

Trial contacts and locations

1

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Central trial contact

Fatma KI Abdelgawad, Lecturer; Marwa A Salmoon, MSc

Data sourced from clinicaltrials.gov

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