NCT05249231

Brief Summary

  • The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp.
  • primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4
  • secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

December 31, 2021

Last Update Submit

February 18, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • parental satisfaction of Hall technique versus silver diamine fluoride

    To estimate parental satisfaction with treatment, parents are going to be asked, "What's the level of your satisfaction with the treatment your child received? "Using a 4 point likert scale (very low equals 1, low equals 2, medium equals 3 and high equals 4)

    during procedure

Secondary Outcomes (1)

  • treatment time

    during procedure

Study Arms (2)

Hall technique

ACTIVE COMPARATOR

group of carious primary molars to be treated by hall technique

Device: Hall technique

silver diamine fluoride

EXPERIMENTAL

group of carious primary molars to be treated by silver diamine fluoride

Drug: Silver diamine fluoride

Interventions

Previous studies have recommended silver diamine fluoride (SDF) to exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The result is useful in arresting early childhood caries (ECC)

Also known as: SDF
silver diamine fluoride

The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method

Also known as: HT
Hall technique

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age: from 4 to 6 years old
  • primary molars with enamel/dentin caries without pulp exposure

You may not qualify if:

  • signs and symptoms of necrosis
  • root caries
  • spontaneous pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ebrahimi M, Shirazi AS, Afshari E. Success and Behavior During Atraumatic Restorative Treatment, the Hall Technique, and the Stainless Steel Crown Technique for Primary Molar Teeth. Pediatr Dent. 2020 May 15;42(3):187-192.

Related Links

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

  • Sherif B Eltaweil, prof

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Hadeer E alazhary, B.D.S

CONTACT

Ahmed M Elkhadem, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2021

First Posted

February 21, 2022

Study Start

April 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 30, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02