Carious Primary MolarsNCT07605689
Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars
A study testing Group A: Chemo-Mechanical Caries Removal (CMCR) and Group 2 :Atraumatic Restorative Treatment in people with Carious Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Primary Molars
- What is being tested?
- Group A: Chemo-Mechanical Caries Removal (CMCR) and Group 2 :Atraumatic Restorative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Oct 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged between 5 and 9 years.
- Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement.
- Children whose parents or guardians have provided written informed consent.
Who cannot join
- 1-Children with teeth exhibiting: pulpal exposure, mobility, spontaneous pain, swelling or fistula adjacent to the tooth, furcation involvement, ervical lesions, teeth with sealants, restorations, or enamel defects also exclude .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maram Malik Osman Alabd, Bachelor of dental science contact
Manal Ahmed Elsheikh, prof, PhD contact
Egypt1 site
Faulty of Dentistry Cairo University
Cairo, 12613
Faculty of Dentistry Cairo university, 00201279666507, rec@dentistry.cu.edu.eg
About this study
The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars.
The main questions it aims to answer: "Does chemo-mechanical caries removal show similar results compared to Atraumatic restorative treatment Method in terms of pain perception in Primary Molars?
Read the detailed description
The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques "high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia
Atraumatic Restorative Treatment (ART) is one of the approaches based on this philosophy. It involves the manual removal of carious tissue without the use of local anesthesia or rotary instruments, followed by restoration with glass ionomer cement, an adhesive material that chemically bonds to tooth structure and releases fluoride, promoting remineralization.
Chemo mechanical caries removal (CMCR) is another minimally invasive technique that utilizes chemical agents with proteolytic action to degrade denatured collagen within carious dentin, facilitating its removal without the need for rotary instruments. This technique reduces pain, discomfort, and anxiety, making it particularly suitable for pediatric patients. Additionally, CMCR minimizes the risk of unnecessary removal of healthy tooth structure and may reduce the need for local anesthesia, thereby improving patient cooperation and the overall treatment experience.
- Conditions
- Carious Primary Molars
- Being tested
- Group A: Chemo-Mechanical Caries Removal (CMCR), Group 2 :Atraumatic Restorative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Chemo-Mechanical Caries Removal (CMCR)Other
Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
Group 2 :Atraumatic Restorative TreatmentOther
Removal of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Chemo-Mechanical Caries Removal (CMCR) | Experimental | Participants in this arm will receive chemo-mechanical caries removal using REMOVE gel. The procedure includes cleaning the tooth surface with wet cotton pellets, application of REMOVE gel into the cavity, and allowing it to act for approximately 30 seconds. The softened carious tissue is then removed gently without pressure. Remaining Caries become fluorescence under light cure source, and the absence of color change indicates complete removal. Residual gel is removed using sterile wet cotton pellets. Finally, the cavity is restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions. Receives: Other: Group A: Chemo-Mechanical Caries Removal (CMCR) |
| Group B: Atraumatic Restorative Treatment (ART) | Experimental | Participants in this arm will receive atraumatic restorative treatment (ART). The procedure involves opening the cavity and removal of carious dentin using a dental excavator . The cavity is clinically evaluated using a sharp explorer, and caries removal is considered complete when the explorer does not stick to dentin or produce a tug-back sensation. The cavity is then restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions. Receives: Other: Group 2 :Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception Measured by Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores represent greater pain intensity.
0: No pain 1-3: mild 4-5: moderate 6-7: Severe 8-9: very severe 10: Worst Pain possible
Measured: immediately after caries removal
Secondary outcomes (1)
Patient Acceptability Assessed by Likert Scale
Patient acceptability will be evaluated using a 5-point Likert Scale ranging from 1 to 5, where 1 indicates very happy and 5 indicates very unhappy. Higher scores indicate lower patient acceptability.
- Very Happy
- Happy
- Neither
- Unhappy
- Very Unhappy
Measured: Immediately after treatment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carious Primary MolarsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram malik osman alabd, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605689
- Sponsor's protocol ID
- PP-NCV-VSART
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
-Abdel Sattar, R., Nasr, R., Hanafy, R. (2026). 'Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial', Egyptian Dental Journal, 72(1), pp. 25-33. doi: 10.21608/edj.2025.417407.3615
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars
- ClinicalTrials.gov ID
- NCT07605689
- Acronym / sponsor ID
- PP-NCV-VSART
- Conditions
- Carious Primary Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 May 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.
The goal of this clinical trial is to compare pain Perception, patient acceptability, and cavity preparation time between chemo-mechanical caries removal and Atraumatic restorative treatment Method in Primary Molars.
The main questions it aims to answer: "Does chemo-mechanical caries removal show similar results compared to Atraumatic restorative treatment Method in terms of pain perception in Primary Molars?
Detailed description
The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques "high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia
Atraumatic Restorative Treatment (ART) is one of the approaches based on this philosophy. It involves the manual removal of carious tissue without the use of local anesthesia or rotary instruments, followed by restoration with glass ionomer cement, an adhesive material that chemically bonds to tooth structure and releases fluoride, promoting remineralization.
Chemo mechanical caries removal (CMCR) is another minimally invasive technique that utilizes chemical agents with proteolytic action to degrade denatured collagen within carious dentin, facilitating its removal without the need for rotary instruments. This technique reduces pain, discomfort, and anxiety, making it particularly suitable for pediatric patients. Additionally, CMCR minimizes the risk of unnecessary removal of healthy tooth structure and may reduce the need for local anesthesia, thereby improving patient cooperation and the overall treatment experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Chemo-Mechanical Caries Removal (CMCR) | Experimental | Other: Group A: Chemo-Mechanical Caries Removal (CMCR)Participants in this arm will receive chemo-mechanical caries removal using REMOVE gel. The procedure includes cleaning the tooth surface with wet cotton pellets, application of REMOVE gel into the cavity, and allowing it to act for approximately 30 seconds. The softened carious tissue is then removed gently without pressure. Remaining Caries become fluorescence under light cure source, and the absence of color change indicates complete removal. Residual gel is removed using sterile wet cotton pellets. Finally, the cavity is restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions. |
| Group B: Atraumatic Restorative Treatment (ART) | Experimental | Other: Group 2 :Atraumatic Restorative TreatmentParticipants in this arm will receive atraumatic restorative treatment (ART). The procedure involves opening the cavity and removal of carious dentin using a dental excavator . The cavity is clinically evaluated using a sharp explorer, and caries removal is considered complete when the explorer does not stick to dentin or produce a tug-back sensation. The cavity is then restored with high-viscosity glass ionomer cement (Fuji IX, GC Corporation, Tokyo, Japan) according to the manufacturer's instructions. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children aged between 5 and 9 years.
- Children presenting with occlusal caries in mandibular and/or maxillary primary molars Carious lesions without any pulpal involvement.
- Children whose parents or guardians have provided written informed consent.
Key exclusion criteria (1 listed)
- 1-Children with teeth exhibiting: pulpal exposure, mobility, spontaneous pain, swelling or fistula adjacent to the tooth, furcation involvement, ervical lesions, teeth with sealants, restorations, or enamel defects also exclude .
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 |
|---|---|---|
| Group A: Chemo-Mechanical Caries Removal (CMCR)Removal of dental caries using REMOVE gel followed by restoration with high-viscosity glass ionomer cement (Fuji IX) | Other | Group A: Chemo-Mechanical Caries Removal (CMCR) |
| Group 2 :Atraumatic Restorative TreatmentRemoval of dental caries using hand instruments followed by restoration with high-viscosity glass ionomer cement (Fuji IX) | Other | Group B: Atraumatic Restorative Treatment (ART) |
Primary outcome
Pain Perception Measured by Visual Analog Scale (VAS)
Time frame: immediately after caries removal
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). Higher scores represent greater pain intensity. 0: No pain 1-3: mild 4-5: moderate 6-7: Severe 8-9: very severe 10: Worst Pain possible
1 secondary outcome
Patient Acceptability Assessed by Likert Scale
Time frame: Immediately after treatment procedure
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 26 May 2026.
- Background-Abdel Sattar, R., Nasr, R., Hanafy, R. (2026). 'Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial', Egyptian Dental Journal, 72(1), pp. 25-33. doi: 10.21608/edj.2025.417407.3615
- Individual participant dataSharing planned: No
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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.
Maram Malik Osman Alabd, Bachelor of dental science contact
Manal Ahmed Elsheikh, prof, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Chemo-Mechanical Caries Removal (CMCR) and Group 2 :Atraumatic Restorative Treatment in people with Carious Primary Molars, 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 3 inclusion and 1 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 26 May 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 Maram Malik Osman Alabd, Bachelor of dental science (00201279666507, maram.alabd@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception Measured by Visual Analog Scale (VAS) (time frame: immediately after caries removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605689, which also lists 1 linked publication.
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 26 May 2026.