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Randomized Controlled Trial on the Effectiveness of Silver Diamine Fluoride in Arresting Caries in Children in Lagos Southwest Nigeria

Phase 3
Conditions
Oral Health
Registration Number
PACTR201908699150281
Lead Sponsor
Dr OKECHUKWU MOSES AZUOR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
214
Inclusion Criteria

a.Age: 3 -10 years
b.Sex: Male and female
c.Children with dental caries ICDAS 5 or 6.
d.Children with signed consent form from parenuardians.
e.Children who sign or thumb print the assent form.
f.Children that will allow oral examination and application of intervention drug/placebo

Exclusion Criteria

a.A child with symptomatic caries tooth (toothache or sensitivity).
b.A child with mobile carious tooth.
c.Children with dental caries ICDAS 0-4.
d.A child that is allergic to silver or heavy metals
e.A child with Amelogenesis or Dentinogenesis Imperfecta.
f.A child with oral ulceration, stomatitis, swelling or abscess.
g.A child with cooperation challenge.
h.A child that is obviously mentally retarded.
i.A child with systemic illness like Asthma, Epilepsis, Leukaemia, Kidney disease.
j.A child whose parent or guardian cannot understand the consent documentation.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary Outcome - Arrested Caries. Secondary Outcome - Toothache, tooth sensitivity,stain, nausea, vomiting, silver allergy, oral soft tissue ulceration, rashes and any other possible dental complications.
Secondary Outcome Measures
NameTimeMethod
Toothache/Sensitivity
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