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Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

Clinical Assessment of Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth (Randomized Control Clinical Trial)

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06759311
Enrollment
88
Registered
2025-01-06
Start date
2024-10-01
Completion date
2025-02-20
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries in Children

Keywords

Minimal Invasive Dentistry

Brief 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.

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)

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
pain scoresImmediately after the interventionWong-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.
caries removal timeDuring procedureThe total working time required for caries removal will be recorded in minutes using a stopwatch
Caries removal efficacyImmediately after the interventionThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026