Clinical Comparison of Cariclast Gel and Rotary Drilling Technique for Caries Removal in 2d Primary Molars (CARICLAST-RCT)

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dental Caries in Primary Molars

Treatments: Procedure: cares removal using cariclast gel; Procedure: Conventional Mechanical Caries Removal

Study type: Interventional

Funder types: Other

Identifiers

NCT07270458

NK2025-CARICLAST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children:

  1. children aged 4-7 years
  2. in good general health, and medically free according to parent history.
  3. Cooperative patients
  4. Children whom their parents will comply with follow-ups.
  5. Children whom their parents who accept to sign informed consent

Tooth:

1. Broad cavitated occlusal lesion with dentinal involvement
2. (Black's Class I cavity) and occlusal access.
3. Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
4. The consistency of carious lesions ranges from soft to medium hard.
5. Color of carious lesion ranges from light yellow to brown

Exclusion criteria

• Children:

  1. Medically or developmentally compromising conditions
  2. Children who will be unable to attend follow-up visits.
  3. Children whom their parents refuse to give written formed consent.

Teeth:

1. Cases requiring restorative treatment that is not of the Class I variety.
2. Extensively damaged teeth.
3. Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
4. Caries involving pulp or extending below the gingiva.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

cariclast group

Experimental group

Description:

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.

Treatment:

Procedure: cares removal using cariclast gel

Conventional Mechanical Caries Removal

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Mechanical Caries Removal