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

April 18, 2026 updated by: Noran Mohamed Kamel Bayoumi, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: cares removal using cariclast gel
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
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the caries removal procedure (immediate intraoperative assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Acceptance of the Caries Removal Technique
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.
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: randa youssef abdelgawad, professor, Cairo University
  • Study Director: rana sobhy saeed, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NK2025-CARICLAST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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