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Not yet recruitingNCT07344415Updated Jan 15, 2026

Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods

An interventional study of Cariemove and Drilling using bur in Caries Active, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
10 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Caries Active

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Keywords

  • Chemo-mechanical
  • Rotary
  • Anxiety
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Chemo-mechanical

    Procedure: Cariemove

  • Active comparator
    Conventional rotary

    Procedure: Drilling using bur

Interventions

  • ProcedureCariemove

    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.

  • ProcedureDrilling using bur

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

06

What researchers measure

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)

    Time frame: Baseline (Day 1)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because of privacy concerns and institutional policy restrictions.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07344415
Lead sponsor
Cairo University
Responsible party
Yasmine Ashraf Elbanna (Lecturer, Department of Conservative Dentistry, Cairo University) — Principal investigator
First posted
Jan 15, 2026
Start date
Dec 31, 2025 (estimated)
Primary completion
Jan 15, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Jan 15, 2026

Study contacts

Manar ELMOKANEN, PhD
Contact
manar_ahmed@dentistry.cu.edu.eg
+20 10 94501210

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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