Clinical Comparison of Cariclast Gel and Rotary Drilling Technique for Caries Removal in 2d Primary Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries in Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cares removal using cariclast gel

Intervention Type PROCEDURE

Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.

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.

Group Type ACTIVE_COMPARATOR

Conventional Mechanical Caries Removal

Intervention Type PROCEDURE

Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.

Interventions

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cares removal using cariclast gel

Chemomechanical caries removal using Cariclast gel applied to soften infected dentin, followed by gentle excavation with hand instruments.

Intervention Type PROCEDURE

Conventional Mechanical Caries Removal

Conventional mechanical caries removal performed using a high-speed rotary handpiece under adequate water cooling, following standard clinical principles for primary molars.

Intervention Type PROCEDURE

Other Intervention Names

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Sodium hypochlorite-based CMCR agent

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes