Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment
NCT ID: NCT04654624
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2018-10-12
2019-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Silver Diamine Fluoride
SDF
Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.
Atraumatic Restorative Treatment
ART
Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.
Interventions
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SDF
Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.
ART
Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.
Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
8 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Princess Nourah Bint Abdulrahman University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Assistant Lecturer of Dental Public Health
Principal Investigators
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Amel M Ahmed, Phd
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
Hoda M Abdellatif, PhD
Role: STUDY_CHAIR
College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USA
Sarah I Baghdady, M.Sc
Role: STUDY_CHAIR
Faculty of Dentistry, Alexandria University, Egypt
Wafaa E Abdelaziz, PhD
Role: STUDY_DIRECTOR
Faculty of Dentistry, Alexandria University, Egypt
Mona A ElKateb, PhD
Role: STUDY_DIRECTOR
Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
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.
Other Identifiers
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SDF vs. ART
Identifier Type: -
Identifier Source: org_study_id