Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

December 29, 2024 updated by: Hams Hamed Abdelrahman

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ART
Other: 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
Experimental: Brix 3000
Other: 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.
Experimental: Carie Move
Other: 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.
Experimental: Smart Bur
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the intervention
caries removal time
Time Frame: During procedure
The total working time required for caries removal will be recorded in minutes using a stopwatch
During procedure
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.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

February 20, 2025

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 29, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 29, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 235-25-08-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries in Children

Clinical Trials on ART

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe