Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Study Overview
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Brief Summary
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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

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

Conditions
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Dental Caries, Primary Teeth

Intervention / Treatment
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* Other: Chemomechanical caries removal by Carie-Care
* Other: Mechanical caries removal by Atraumatic Restorative Technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |