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

Primary Purpose

Dental Caries, Child Discomfort

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
SDF
ART
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Silver Diamine Fluoride

Atraumatic Restorative Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parents' acceptability of the treatment modality
It was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.

Full Information

First Posted
November 27, 2020
Last Updated
November 27, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University, Princess Nourah Bint Abdulrahman University
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1. Study Identification

Unique Protocol Identification Number
NCT04654624
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University, Princess Nourah Bint Abdulrahman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Child Discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silver Diamine Fluoride
Arm Type
Experimental
Arm Title
Atraumatic Restorative Treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SDF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain perception
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Parents' acceptability of the treatment modality
Description
It was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amel M Ahmed, Phd
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hoda M Abdellatif, PhD
Organizational Affiliation
College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah I Baghdady, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wafaa E Abdelaziz, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mona A ElKateb, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
1815200
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.
Results Reference
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PubMed Identifier
17518963
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.
Results Reference
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Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment

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