Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

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

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

Study Overview

• Status: Recruiting
• Conditions: Dental Caries; Primary Teeth
• Intervention / Treatment: Other: Chemomechanical caries removal by Carie-Care; Other: Mechanical caries removal by Atraumatic Restorative Technique

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa Y Ghanem, BDS; Phone Number: 01020208494; Email: Alaaghanem952@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Alaa Y Ghanem, BDS; Phone Number: 01020208494; Email: Alaaghanem952@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Mechanical caries removal by Atraumatic Restorative Technique; caries in primary teeth will be removed using the mechanical caries removal by ART method.
Experimental: Test	Other: Chemomechanical caries removal by Carie-Care; caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Caries Removal 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No