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

NCT04654624 | Completed Phase 2

• 1 other identifier: SDF vs. ART
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Child Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parents' acceptability of the treatment modality

  2 weeks

Study Arms (2)

Silver Diamine Fluoride

EXPERIMENTAL

Drug: SDF

Atraumatic Restorative Treatment

ACTIVE COMPARATOR

Drug: ART

Interventions

SDF DRUG

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.

Silver Diamine Fluoride

ART DRUG

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.

Atraumatic Restorative Treatment

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator
• Princess Nourah Bint Abdulrahman University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (2)

• 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.

  PMID: 1815200 BACKGROUND

• 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.

  PMID: 17518963 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Amel M Ahmed, Phd

  Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Hoda M Abdellatif, PhD

  College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia and College of Dentistry Texas A&M University, Texas, USA

  STUDY CHAIR

• Sarah I Baghdady, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Wafaa E Abdelaziz, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Mona A ElKateb, PhD

  Faculty of Dentistry, Alexandria University, Egypt and College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: October 12, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 30, 2019
• Last Updated: December 4, 2020

Record last verified: 2020-11

Locations

EG (1)