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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05538559
Enrollment
48
Registered
2022-09-14
Start date
2022-06-01
Completion date
2022-10-30
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Primary Teeth

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

Interventions

OTHERChemomechanical caries removal by Carie-Care

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

OTHERMechanical caries removal by Atraumatic Restorative Technique

caries in primary teeth will be removed using the mechanical caries removal by ART method.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time taken for caries removalThrough procedure completionThe 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 removalThrough procedure completionCaries 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 perceptionThrough procedure completionThe 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 behaviorThrough procedure completionScore 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.

Countries

Egypt

Contacts

Primary ContactAlaa Y Ghanem, BDS
Alaaghanem952@gmail.com01020208494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026