Clinical trial NCT04654624: Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment
Official title: Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Caries
Child Discomfort
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
name: Princess Nourah Bint Abdulrahman University
First posted: 2020-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.

Detailed description: Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.

Eligibility criteria: Inclusion Criteria:

* Negative and definitely negative behavior according to Frankl's behavior rating scale.
* Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.

Exclusion Criteria:

* Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.

Primary outcomes:
measure: Pain perception
timeFrame: 6 months
Secondary outcomes:
measure: Parents' acceptability of the treatment modality
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
name: Amel M Ahmed, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USA
name: Hoda M Abdellatif, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Sarah I Baghdady, M.Sc
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Wafaa E Abdelaziz, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
name: Mona A ElKateb, PhD
role: STUDY_DIRECTOR
References:
citation: Wright GZ, Weinberger SJ, Marti R, Plotzke O. The effectiveness of infiltration anesthesia in the mandibular primary molar region. Pediatr Dent. 1991 Sep-Oct;13(5):278-83.
citation: Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.