Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

NCT07344415 | Not Yet Recruiting

• 1 other identifier: Cariemove
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries Active

Keywords

Chemo-mechanical; Rotary; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Chemo-mechanical

EXPERIMENTAL

Procedure: Cariemove

Conventional rotary

ACTIVE COMPARATOR

Procedure: Drilling using bur

Interventions

Cariemove 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.

Chemo-mechanical

Drilling using bur PROCEDURE

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

Conventional rotary

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Open carious lesions with dentin involvement, but not involving the pulp in lower molars.
• The access of the carious lesion has to be large enough to allow the penetration of the excavator.
• Asymptomatic vital teeth, without clinical evidence of pulp, furcation, or periapical pathology.
• Patients who sign informed consent.
• Co-operative patients approving to participate in the trial.

You may not qualify if:

• Patients with spontaneous or elicited pain from caries.
• Patients with systemic diseases.
• Presence of intraoral/extraoral swellings.
• Deep dental caries involving pulp.
• Presence of swelling/fistula in relation to carious tooth.
• Inability to return for recall visits.
• Patients with bad oral hygiene
• Refuse to participate in the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Manar ELMOKANEN, PhD

CONTACT

+20 10 94501210; manar_ahmed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Conservative Dentistry

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 15, 2026
• Study Start: December 31, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)