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Clinical Trials/NCT06759311
NCT06759311
Active, not recruiting
Not Applicable

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

Hams Hamed Abdelrahman1 site in 1 country88 target enrollmentOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries in Children
Sponsor
Hams Hamed Abdelrahman
Enrollment
88
Locations
1
Primary Endpoint
pain scores
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
February 20, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hams Hamed Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Alexandria University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

caries removal time

Time Frame: During procedure

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

Caries removal efficacy

Time Frame: 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.

Study Sites (1)

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