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Status unknownNCT05538559Updated Sep 14, 2022

Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth

An interventional study of Chemomechanical caries removal by Carie-Care and Mechanical caries removal by Atraumatic Restorative Technique in Dental Caries and Primary Teeth, sponsored by Hams Hamed Abdelrahman. Status unknown at 1 site in Egypt. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2022, registered Sep 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study 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

02

Conditions studied

  • Dental Caries
  • Primary Teeth

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's planned enrollment of 48 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
  • Proximal caries evidenced by bitewing x-ray
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Test

    Other: Chemomechanical caries removal by Carie-Care

  • Active comparator
    Control

    Other: Mechanical caries removal by Atraumatic Restorative Technique

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through procedure completion

  2. 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

    Time frame: Through procedure completion

  3. 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)

    Time frame: Through procedure completion

  4. 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.

    Time frame: Through procedure completion

07

Study locations

1 of 1 sites recruiting
  • Alexandria Faculty of Dentistry
    Alexandria, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05538559
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Sep 14, 2022
Start date
Jun 1, 2022
Primary completion
Oct 30, 2022 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Sep 14, 2022

Study contacts

Alaa Y Ghanem, BDS
Contact
Alaaghanem952@gmail.com
01020208494

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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