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NCT Number: NCT06759311

Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Caries in Children

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Art

Other

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

Other

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

Other

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

Other

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)

Primary outcomes

  1. pain scores

    Time frame: 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.

  2. caries removal time

    Time frame: During procedure

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

  3. Caries removal efficacy

    Time frame: Immediately after the intervention

    The caries removal criteria:

    0 Caries removed completely

    • Caries noticed at the base of the cavity
    • Caries noticed at the base and/or one wall of the cavity
    • Caries noticed at the base and/or two walls of the cavity
    • Caries noticed at the base and/or more than two walls of the cavity
    • Caries noticed at the base, walls and margins of the cavity.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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