Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

NCT05538559 | Unknown

• 1 other identifier: Caries Removal 2022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Caries; Primary Teeth

Outcome Measures

Primary Outcomes (4)

• 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Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn.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

Study Arms (2)

Test

EXPERIMENTAL

Other: Chemomechanical caries removal by Carie-Care

Control

ACTIVE COMPARATOR

Other: Mechanical caries removal by Atraumatic Restorative Technique

Interventions

Chemomechanical caries removal by Carie-Care OTHER

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

Test

Mechanical caries removal by Atraumatic Restorative Technique OTHER

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

Control

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
• Proximal caries evidenced by bitewing x-ray

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Alaa Y Ghanem, BDS

CONTACT

01020208494; Alaaghanem952@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 14, 2022
• Study Start: June 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

EG (1)