Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

Sponsor

Hams Hamed Abdelrahman (Other)

Overall Status

Recruiting

CT.gov ID

NCT05538559

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dental Caries Primary Teeth	Other: Chemomechanical caries removal by Carie-Care Other: Mechanical caries removal by Atraumatic Restorative Technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test	Other: Chemomechanical caries removal by Carie-Care caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.
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.

Arm

Intervention/Treatment

Experimental: Test

Other: Chemomechanical caries removal by Carie-Care

caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.

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.

Outcome Measures

Primary Outcome Measures

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.
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 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)
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Dentistry	Alexandria		Egypt

Sponsors and Collaborators

Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University

ClinicalTrials.gov Identifier:

NCT05538559

Other Study ID Numbers:

Caries Removal 2022

First Posted:

Sep 14, 2022

Last Update Posted:

Sep 14, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Sep 14, 2022