Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

Level of Anxiety During Caries Removal Using a New Chemo-mechanical Caries Removal System Versus Conventional Drilling Method: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries Active
• Intervention / Treatment: Procedure: Cariemove; Procedure: Drilling using bur

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manar ELMOKANEN, Phd; Phone Number: +20 10 94501210; Email: manar_ahmed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Cairo University
    • Contact: Manar ELMOKANEN, Phd; Phone Number: +20 10 94501210; Email: manar_ahmed@dentistry.cu.edu.eg
    • Contact: Hadir Gad, Phd; Phone Number: +20 10 67838532; Email: hadeer.ahmed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemo-mechanical	Procedure: 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.
Active Comparator: Conventional rotary	Procedure: Drilling using bur; Rotary dental burs using high speed hand piece under water spray cooling system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of anxiety and discomfort	Visual Analogue Scale from 0 to 10 (0 represents no pain and 10 represents the worst pain)	Baseline (Day 1)

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Rotary; Chemo-mechanical
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Cariemove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because of privacy concerns and institutional policy restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No