Caries ActiveNCT07344415
Anxiety During Caries Removal Using Chemo-mechanical Versus Conventional Methods
A study testing Cariemove and Drilling using bur in people with Caries Active, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Caries Active
- What is being tested?
- Cariemove and Drilling using bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Dec 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry Cairo University
Cairo
Manar ELMOKANEN, Phd, +20 10 94501210, manar_ahmed@dentistry.cu.edu.eg
Hadir Gad, Phd, +20 10 67838532, hadeer.ahmed@dentistry.cu.edu.eg
About this study
Official title: 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.
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.
- Conditions
- Caries Active
- Being tested
- Cariemove, Drilling using bur
- Keywords
- Chemo-mechanical, Rotary, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariemoveProcedure or surgery
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 burProcedure or surgery
Rotary dental burs using high speed hand piece under water spray cooling system
| Study group | Role | What they receive |
|---|---|---|
| Chemo-mechanical | Experimental | Not described Receives: Procedure: Cariemove |
| Conventional rotary | Active comparator | Not described Receives: Procedure: Drilling using bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety and discomfort
Visual Analogue Scale from 0 to 10 (0 represents no pain and 10 represents the worst pain)
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ActiveStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Ashraf Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344415
- Sponsor's protocol ID
- Cariemove
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because of privacy concerns and institutional policy restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Anxiety During Caries Removal Using a New Chemo-mechanical Caries Removal System Versus Conventional Drilling Method: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344415
- Acronym / sponsor ID
- Cariemove
- Conditions
- Caries Active
- Keywords
- Chemo-mechanical, Rotary, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo-mechanical | Experimental | Procedure: Cariemove |
| Conventional rotary | Active comparator | Procedure: Drilling using bur |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CariemoveIt 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. | Procedure or surgery | Chemo-mechanical |
| Drilling using burRotary dental burs using high speed hand piece under water spray cooling system | Procedure or surgery | Conventional rotary |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because of privacy concerns and institutional policy restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cariemove and Drilling using bur in people with Caries Active, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manar ELMOKANEN, PhD (+20 10 94501210, manar_ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of anxiety and discomfort (time frame: Baseline (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.