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Active, not recruitingNCT06759311Updated Jan 6, 2025

Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

An interventional study of ART and Brix 3000 in Dental Caries in Children, sponsored by Hams Hamed Abdelrahman. Active, not recruiting at 1 site in Egypt. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
4 Years to 8 Years
Sex
All
01

Study summary

Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment (ART), chemo-mechanical caries removal and smart bur.

02

Conditions studied

  • Dental Caries in Children

Keywords

  • Minimal Invasive Dentistry
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 111 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Each child has three teeth with carious cavity enough for insertion of hand instruments
  • Positive or definitely positive child behaviour according to the Frankl Behaviour Scale (FBS)
  • Caries lesion in dentin of primary teeth

Exclusion criteria

Exclusion Criteria:

  • Negative" or "definitely negative" child behaviour according to the FBS.
  • Presence of sign and symptoms of pulp lesion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • Active comparator
    ART

    Other: ART

  • Experimental
    Brix 3000

    Other: Brix 3000

  • Experimental
    Carie Move

    Other: Carie Move

  • Experimental
    Smart Bur

    Other: Smart Bur

Interventions

  • OtherART

    The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin

  • OtherBrix 3000

    Brix 3000 gel will be applied to the caries lesion using a spoon excavator\*\* leaving gel according to the manufacturer's instructions. After 2 minutes, the gel will turn from translucent green colour to cloudy after the gel removal.

  • OtherCarie Move

    Carie-Move gel will be applied to the caries lesion according to the manufacturer's instructions at second visit in the same child. After 30 second the gel will be removed.

  • OtherSmart Bur

    Removal of carious dentin will be carried out employing smart bur II mounted on a low-speed handpiece without water spray. Caries removal will be proceeded until the smart bur II becomes dull after repeated contact with healthy dentin (21) (figure 3)

06

What researchers measure

Primary outcomes

  1. pain scores

    Wong-Baker Faces Pain Rating Scale (WBFPS) Presents 6 faces with increasing degrees of pain from left to right. Each face was attributed a scale from 0 to 10 indicated onthe scale. Children were asked to choose the face that best describe his or her pain.

    Time frame: Immediately after the intervention

  2. caries removal time

    The total working time required for caries removal will be recorded in minutes using a stopwatch

    Time frame: During procedure

  3. Caries removal efficacy

    The caries removal criteria: 0 Caries removed completely 1. Caries noticed at the base of the cavity 2. Caries noticed at the base and/or one wall of the cavity 3. Caries noticed at the base and/or two walls of the cavity 4. Caries noticed at the base and/or more than two walls of the cavity 5. Caries noticed at the base, walls and margins of the cavity.

    Time frame: Immediately after the intervention

07

Study locations

1 site
  • Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
    Alexandria, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Jan 2025, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 23, 2024
First posted
Jan 6, 2025
StartActual
Oct 1, 2024
Primary completionEst.
Jan 30, 2025
CompletionEst.
Feb 20, 2025
Last update
Jan 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06759311
Responsible party
Hams Hamed Abdelrahman (Assistant Lecturer of Dental Public Health and biostatistical consultanat, Alexandria University) — Sponsor-investigator
First posted
Jan 6, 2025
Start date
Oct 1, 2024
Primary completion
Jan 30, 2025 (estimated)
Completion
Feb 20, 2025 (estimated)
Last update
Jan 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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