Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment

Dental Caries Clinical Trial

Official title:

Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654624
• Other study ID #: SDF vs. ART
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 12, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Discomfort
• Dental Caries

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (3)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University, Princess Nourah Bint Abdulrahman University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception	Pain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.	6 months
Secondary	Parents' acceptability of the treatment modality	It was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.	2 weeks