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Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Primary Purpose

Dental Caries, Primary Teeth

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Chemomechanical caries removal by Carie-Care
Mechanical caries removal by Atraumatic Restorative Technique
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

5 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandria Faculty of DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Control

Arm Description

Outcomes

Primary Outcome Measures

Time taken for caries removal
The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.
Efficacy of caries removal
Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity
Child pain perception
The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)
Child behavior
Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation. Score 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. Score 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn. Score 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2022
Last Updated
September 10, 2022
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT05538559
Brief Title
Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth
Official Title
The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Primary Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Chemomechanical caries removal by Carie-Care
Intervention Description
caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.
Intervention Type
Other
Intervention Name(s)
Mechanical caries removal by Atraumatic Restorative Technique
Intervention Description
caries in primary teeth will be removed using the mechanical caries removal by ART method.
Primary Outcome Measure Information:
Title
Time taken for caries removal
Description
The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.
Time Frame
Through procedure completion
Title
Efficacy of caries removal
Description
Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity
Time Frame
Through procedure completion
Title
Child pain perception
Description
The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)
Time Frame
Through procedure completion
Title
Child behavior
Description
Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation. Score 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. Score 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn. Score 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.
Time Frame
Through procedure completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Y Ghanem, BDS
Phone
01020208494
Email
Alaaghanem952@gmail.com
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Y Ghanem, BDS
Phone
01020208494
Email
Alaaghanem952@gmail.com

12. IPD Sharing Statement

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Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

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