Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

NCT06759311 | Active Not Recruiting

• 1 other identifier: 235-25-08-2024
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Keywords

Minimal Invasive Dentistry

Outcome Measures

Primary Outcomes (3)

• 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.

  Immediately after the intervention

• caries removal time

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

  During procedure

• 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.

  Immediately after the intervention

Study Arms (4)

ART

ACTIVE COMPARATOR

Other: ART

Brix 3000

EXPERIMENTAL

Other: Brix 3000

Carie Move

EXPERIMENTAL

Other: Carie Move

Smart Bur

EXPERIMENTAL

Other: Smart Bur

Interventions

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

ART

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.

Brix 3000

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.

Carie Move

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)

Smart Bur

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

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

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 6, 2025
• Study Start: October 1, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 20, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

EG (1)