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Clinical Trials in Egypt / NCT06759311
Active, not recruiting Not applicable

Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

NCT06759311 · tracked via the Priya Life Science Egypt tracker
Sponsor
Hams Hamed Abdelrahman
Phase
Not applicable
Started
2024-10-01
Last updated
2025-01-06

Condition(s) studied

Dental Caries in Children

Investigational drug(s) / intervention(s)

ARTBrix 3000Carie MoveSmart Bur

ART: 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

Brix 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.

Carie 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.

Smart 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)

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
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

Primary outcome measure(s)

  • pain scores — Immediately after the intervention
    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.
  • caries removal time — During procedure
    The total working time required for caries removal will be recorded in minutes using a stopwatch
  • Caries removal efficacy — Immediately after the intervention
    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.

Trial sites (1)

FacilityCityRegionStatus
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt Alexandria Egypt

More Hams Hamed Abdelrahman trials in Egypt

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Other trials for the same condition

Maternal Control of the Child's Feeding, Child's Eating Behavior and Early Childhood Caries in Preschoolers Enrolling by invitation
Clinical and Radiographic Evaluation of Injectable Composite Versus Packable Composite in Restoring of Primary Molars Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759311 on ClinicalTrials.gov ↗ ← All trials in Egypt