Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

NCT ID: NCT07344415

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-01-31

Brief Summary

This study aims to clinically assess this newly introduced Egyptian chemo-mechanical caries removal gel versus conventional drilling method . The concept of preserving healthy tooth structures and employing atraumatic restorative techniques during cavity preparation aligns with the principles of minimally invasive dentistry. This approach prioritizes patient comfort, reassurance, and fosters a positive perception of dental treatment.

Detailed Description

Dental caries is a multifactorial dynamic disease that involves mineral loss of dental hard tissue. Caries management is the action made to interfere with the loss of minerals that could be non-operative or operative interventions according to the stage and severity of the case. In deep carious lesions, removal of caries using rotary instruments has been the most prevalent technique. This could be attributed to being rapid and efficient in caries removal. However, such technique possesses some drawbacks in terms of patient discomfort, thermal stimulation to the pulp and unnecessary excessive removal of tissues. Minimally invasive dentistry is the philosophy that aims for lesion control as well as minimal operative intervention. Preserving dental tissue by early caries detection of as well as combining non-operative minimally invasive restorative procedures are its main objective. Therefore, alternative techniques have been proposed to overcome the drawbacks of rotary instrumentation of deep lesions. One of the techniques is chemico-mechanical caries removal. Chemico-mechanical caries removal is based on enzymatic action on carious tissues dissolving them to be easily removed using an excavator. Such system allows better patient perception by avoiding the vibration caused by rotary instruments. It also helps in avoiding excessive pulpal irritation caused by the heat generated while using rotary instruments. Cariemove ,a newly introduced Egyptian product, that is based on amino acids, sodium hypochlorite and carboxyglyciene has been introduced in the market. This system lacks sufficient literature about its clinical efficiency and level of anxiety of patients during caries removal.

Conditions

Caries Active

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chemo-mechanical

Group Type: EXPERIMENTAL

Cariemove

Intervention Type: PROCEDURE

It is a newly introduced Egyptian product. It consists of a transparent liquid containing 0.5% sodium hypochlorite, 0.1 M mixtures of three amino acids, leucine, lysine and glutamic acid.

Conventional rotary

Group Type: ACTIVE_COMPARATOR

Drilling using bur

Intervention Type: PROCEDURE

Rotary dental burs using high speed hand piece under water spray cooling system

Interventions

Cariemove

It is a newly introduced Egyptian product. It consists of a transparent liquid containing 0.5% sodium hypochlorite, 0.1 M mixtures of three amino acids, leucine, lysine and glutamic acid.

Intervention Type: PROCEDURE

Drilling using bur

Rotary dental burs using high speed hand piece under water spray cooling system

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Open carious lesions with dentin involvement, but not involving the pulp in lower molars.

2. The access of the carious lesion has to be large enough to allow the penetration of the excavator.

3. Asymptomatic vital teeth, without clinical evidence of pulp, furcation, or periapical pathology.

4. Patients who sign informed consent.

5. Co-operative patients approving to participate in the trial.

Exclusion Criteria

1. Patients with spontaneous or elicited pain from caries.

2. Patients with systemic diseases.

3. Presence of intraoral/extraoral swellings.

4. Deep dental caries involving pulp.

5. Presence of swelling/fistula in relation to carious tooth.

6. Inability to return for recall visits.

7. Patients with bad oral hygiene

8. Refuse to participate in the study.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Ashraf Elbanna

Lecturer, Department of Conservative Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Manar ELMOKANEN, PhD

Role: CONTACT

manar_ahmed@dentistry.cu.edu.eg

+20 10 94501210

Facility Contacts

Manar ELMOKANEN, Phd

Role: primary

manar_ahmed@dentistry.cu.edu.eg

+20 10 94501210

Hadir Gad, Phd

Role: backup

hadeer.ahmed@dentistry.cu.edu.eg

+20 10 67838532

Other Identifiers

Cariemove

Identifier Type: -

Identifier Source: org_study_id