Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth

NCT ID: NCT06759311

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ART

Group Type ACTIVE_COMPARATOR

ART

Intervention Type 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

Group Type EXPERIMENTAL

Brix 3000

Intervention Type 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

Group Type EXPERIMENTAL

Carie Move

Intervention Type 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

Group Type EXPERIMENTAL

Smart Bur

Intervention Type 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)

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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235-25-08-2024

Identifier Type: -

Identifier Source: org_study_id

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