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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 24
- Primary Endpoint
- Pain Perception During Caries Removal
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children:
- •children aged 4-7 years
- •in good general health, and medically free according to parent history.
- •Cooperative patients
- •Children whom their parents will comply with follow-ups.
- •Children whom their parents who accept to sign informed consent
- •Broad cavitated occlusal lesion with dentinal involvement
- •(Black's Class I cavity) and occlusal access.
- •Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
- •The consistency of carious lesions ranges from soft to medium hard.
Exclusion Criteria
- •Children:
- •Medically or developmentally compromising conditions
- •Children who will be unable to attend follow-up visits.
- •Children whom their parents refuse to give written formed consent.
- •Cases requiring restorative treatment that is not of the Class I variety.
- •Extensively damaged teeth.
- •Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
- •Caries involving pulp or extending below the gingiva.
Arms & Interventions
cariclast group
Participants in this arm will undergo chemomechanical caries removal using Cariclast gel (sodium hypochlorite-based CMCR agent). The gel will be applied on the carious lesion according to the manufacturer's instructions, followed by gentle removal of the softened dentin using hand excavators.
Intervention: cares removal using cariclast gel (Procedure)
Conventional Mechanical Caries Removal
Participants in this arm will undergo conventional mechanical caries removal using a high-speed rotary handpiece under adequate water cooling. The procedure will follow standard clinical principles for removing infected dentin while maintaining a conservative approach to preserve sound tooth structure in primary molars.
Intervention: Conventional Mechanical Caries Removal (Procedure)
Outcomes
Primary Outcomes
Pain Perception During Caries Removal
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.
Secondary Outcomes
- Child Acceptance of the Caries Removal Technique(Immediately after the procedure)
Investigators
Noran Mohamed Kamel Bayoumi
Nora mohamed kamel
Cairo University