cares removal using cariclast gel
ProcedureChemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.
Other names: Sodium hypochlorite-based CMCR agent
NCT Number: NCT07270458
This randomized clinical trial aims to compare two different methods of caries removal in primary molars: the chemomechanical technique using Cariclast gel and the conventional rotary drilling method. The study will evaluate and compare the pain perception, patient acceptance, and operative time associated with both techniques in children aged 5-7years.
Trial opening soon.
Get Notified4 year–7 year
All sexes
Interventional
Not applicable
Dental caries is one of the most common chronic diseases in children, and the management of carious lesions in primary teeth should be both effective and minimally invasive. Traditional caries removal using rotary instruments is associated with discomfort and anxiety among pediatric patients.
Chemomechanical caries removal (CMCR) agents such as Cariclast have been developed as a more conservative and less traumatic alternative. Cariclast works by softening the infected dentin chemically, allowing its gentle removal without pain or vibration.
This randomized controlled clinical trial will compare Cariclast with the conventional rotary drilling method regarding:
Pain perception assessed using the FLACC scale.
Patient acceptance evaluated using the Visual Analog Scale (VAS).
Operative time required to complete the caries removal procedure.
All procedures will be performed on cooperative children with occlusal caries in primary molars, without pulpal involvement, attending the Pediatric Dentistry Department, Faculty of Dentistry, Cairo University.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Tooth:
Exclusion criteria
Teeth:
Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.
Other names: Sodium hypochlorite-based CMCR agent
Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.
Time frame: During the caries removal procedure (immediate intraoperative assessment)
Pain perception will be evaluated using the Wong-Baker FACES Pain Rating Scale. Before starting caries removal, the child will be briefly shown the six facial expressions and given age-appropriate instructions to ensure proper understanding of how to express discomfort. During the procedure, immediately at the moment of peak stimulation, the child will be asked to point to the face that best reflects their pain experience. The selected score (ranging from 0 to 10) will be recorded as an objective standardized measure of procedural pain.
Time frame: Immediately after the procedure
Patient acceptance will be measured immediately after completion of the caries removal procedure using a Visual Analog Scale (VAS). The scale consists of a 100-mm horizontal line with descriptors at each end indicating the extremes of comfort, ranging from "no discomfort" to "worst possible discomfort." Each child will be asked to mark a point on the line that best represents their overall comfort during the procedure. The distance in millimeters from the "no discomfort" anchor to the child's mark will be measured to quantify the level of acceptance. Higher scores indicate lower acceptance of the technique.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Clinical Evaluation of Pain Perception and Patient Acceptance During Chemomechanical Caries Removal Using Cariclast Versus Conventional Caries Removal in 2nd Primary Molars With Occlusal Caries in Children: A Randomized Clinical Trial
Acronym: CARICLAST-RCT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.