Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Not Applicable

Recruiting

• Conditions: Primary Teeth; Dental Caries
• Interventions: Other: Chemomechanical caries removal by Carie-Care; Other: Mechanical caries removal by Atraumatic Restorative Technique

• Registration Number: NCT05538559
• Lead Sponsor: Hams Hamed Abdelrahman

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-10
• Study First Submitted QC: 2022-09-10
• Last Update Submitted: 2022-09-10
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test	Chemomechanical caries removal by Carie-Care	-
Control	Mechanical caries removal by Atraumatic Restorative Technique	-

Primary Outcome Measures

Name	Time	Method
Child pain perception	Through procedure completion	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)
Efficacy of caries removal	Through procedure completion	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 behavior	Through procedure completion	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 taken for caries removal	Through procedure completion	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.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt