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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05538559
Other study ID # Caries Removal 2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date October 30, 2022

Study information

Verified date September 2022
Source Alexandria University
Contact Alaa Y Ghanem, BDS
Phone 01020208494
Email Alaaghanem952@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 8 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chemomechanical caries removal by Carie-Care
caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.
Mechanical caries removal by Atraumatic Restorative Technique
caries in primary teeth will be removed using the mechanical caries removal by ART method.

Locations

Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through procedure completion
Primary 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 Through procedure completion
Primary 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) Through procedure completion
Primary 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.
Through procedure completion
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