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NCT Number: NCT07344415

Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

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.

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Key information

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Drilling using bur

Procedure

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

Primary outcomes

  1. Level of anxiety and discomfort

    Time frame: Baseline (Day 1)

    Visual Analogue Scale from 0 to 10 (0 represents no pain and 10 represents the worst pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Manar ELMOKANEN, PhD

CONTACT

[email protected]

+20 10 94501210

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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