Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

NCT ID: NCT05538559

Last Updated: 2022-09-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-10-30

Brief Summary

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Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure

Detailed Description

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Conditions

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Dental Caries Primary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test

Group Type EXPERIMENTAL

Chemomechanical caries removal by Carie-Care

Intervention Type OTHER

caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.

Control

Group Type ACTIVE_COMPARATOR

Mechanical caries removal by Atraumatic Restorative Technique

Intervention Type OTHER

caries in primary teeth will be removed using the mechanical caries removal by ART method.

Interventions

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Chemomechanical caries removal by Carie-Care

caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.

Intervention Type OTHER

Mechanical caries removal by Atraumatic Restorative Technique

caries in primary teeth will be removed using the mechanical caries removal by ART method.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System\[ICDAS\].
* The access of the carious lesion has to be large enough to allow the penetration of the excavator
* Children with behavior rating 3 or 4 according to the Frankl scale

Exclusion Criteria

* Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
* Proximal caries evidenced by bitewing x-ray
Minimum Eligible Age

5 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 DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Alaa Y Ghanem, BDS

Role: CONTACT

01020208494

Facility Contacts

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Alaa Y Ghanem, BDS

Role: primary

01020208494

Other Identifiers

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Caries Removal 2022

Identifier Type: -

Identifier Source: org_study_id

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