Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Dental Caries Clinical Trial

Official title:

The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538559
• Other study ID #: Caries Removal 2022
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Caries
• Primary Teeth

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