Chemo-Mechanical Caries RemovalNCT06531148
A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
A study testing Chemo-mechanical caries removal in people with Chemo-Mechanical Caries Removal, run by Mansoura University at 2 sites in Egypt.
Trial summary
This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children. The assessed parameters will be: Efficacy of caries removal. Pain reaction and mean time required for the treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chemo-Mechanical Caries Removal
- What is being tested?
- Chemo-mechanical caries removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 31 Jul 2024to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cooperative child
- Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- The selected molars should have normal structure and morphology.
Who cannot join
- 1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Dentistry
Al Mansurah, El-dahlewa, 35516
Dentistry
Al Mansurah, 35516
Mutasim Babiker Zainelabdin Elbashir, Master, +201552575121, dr.mutasimbabiker@gmail.com
Master
About this study
This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.
The assessed parameters will be:
- Efficacy of caries removal.
- Pain reaction and mean time required for the treatment.
- Total bacterial count before and after treatment.
Read the detailed description
Subjects:
A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.
Each child with the following criteria will be eligible for the present study (22).
Inclusion criteria:
- Cooperative child
- Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- The selected molars should have normal structure and morphology.
Exclusion criteria:
- Un-cooperative child
- Molars with clinical and radiographic signs of pulp involvement.
- Children with special health care needs.
- Molars which have already been restored or have developmental anomaly.
- Conditions
- Chemo-Mechanical Caries Removal
- Being tested
- Chemo-mechanical caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemo-mechanical caries removalOther
Chemo-mechanical were be used as a Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material were be done according to the manufacturer's instructions (20). The material will be applied with a blunt spoon excavator and left for 2 minutes allowing the chemistry to work. The decayed dentin which becomes soft (due to the action of the material) was being scraped away using a blunt excavator in a pendulum movement without pressure. If necessary, the procedure will be repeated to get healthy dentin. The cavity will be visually inspected by caries detector dye to assess the complete removal of the carious dentin.
| Study group | Role | What they receive |
|---|---|---|
| Chemo-mechanical caries removal | Experimental | A Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material will be done according to the manufacturer's instructions Receives: Other: Chemo-mechanical caries removal |
| Conventional drilling method | Other | * In this group, caries removal was performed using a low-speed handpiece with a carbon steel round bur.
* The cavities were then examined using the same criteria that had been used with Group I to assess for any remaining caries.
* After caries removal, a dentin sample was taken from the cavity floor in both groups using a sterile sharp spoon excavator.
* The dentin sample was transported to a sterile screw-cap vial for bacterial count examination. Receives: Other: Chemo-mechanical caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation
A-Efficacy:
B- Child satisfaction and pain experience:
C-Time assessment
Measured: 11.2 ± 3.3 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion2 Oct 2024 (estimated)
- Study completion11 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemo-Mechanical Caries RemovalStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- It is a randomized controlled clinical trial with split-mouth technique
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531148
- Sponsor's protocol ID
- A0303023PP
- Status last verified
- Oct 2023
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06531148
- Acronym / sponsor ID
- A0303023PP
- Conditions
- Chemo-Mechanical Caries Removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 2 Oct 2024 (estimated)
- Study completion
- 11 Nov 2024 (estimated)
- First posted
- 31 Jul 2024 (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 will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.
The assessed parameters will be:
- Efficacy of caries removal.
- Pain reaction and mean time required for the treatment.
- Total bacterial count before and after treatment.
Detailed description
Subjects:
A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.
Each child with the following criteria will be eligible for the present study (22).
Inclusion criteria:
- Cooperative child
- Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- The selected molars should have normal structure and morphology.
Exclusion criteria:
- Un-cooperative child
- Molars with clinical and radiographic signs of pulp involvement.
- Children with special health care needs.
- Molars which have already been restored or have developmental anomaly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- It is a randomized controlled clinical trial with split-mouth technique
| Arm | Type | Receives |
|---|---|---|
| Chemo-mechanical caries removal | Experimental | Other: Chemo-mechanical caries removalA Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material will be done according to the manufacturer's instructions |
| Conventional drilling method | Other | Other: Chemo-mechanical caries removal* In this group, caries removal was performed using a low-speed handpiece with a carbon steel round bur. * The cavities were then examined using the same criteria that had been used with Group I to assess for any remaining caries. * After caries removal, a dentin sample was taken from the cavity floor in both groups using a sterile sharp spoon excavator. * The dentin sample was transported to a sterile screw-cap vial for bacterial count examination. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Cooperative child
- Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
- The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
- The selected molars should have normal structure and morphology.
Key exclusion criteria (1 listed)
- 1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.
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 |
|---|---|---|
| Chemo-mechanical caries removalChemo-mechanical were be used as a Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material were be done according to the manufacturer's instructions (20). The material will be applied with a blunt spoon excavator and left for 2 minutes allowing the chemistry to work. The decayed dentin which becomes soft (due to the action of the material) was being scraped away using a blunt excavator in a pendulum movement without pressure. If necessary, the procedure will be repeated to get healthy dentin. The cavity will be visually inspected by caries detector dye to assess the complete removal of the carious dentin. | Other | Chemo-mechanical caries removal, Conventional drilling method |
Primary outcome
Clinical evaluation
Time frame: 11.2 ± 3.3 min
A-Efficacy: B- Child satisfaction and pain experience: C-Time assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemo-mechanical caries removal in people with Chemo-Mechanical Caries Removal, run by Mansoura University at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mutasim Babiker Elbashir, Master (800-555-5555, dr.mutasimbabiker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation (time frame: 11.2 ± 3.3 min). 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 31 Jul 2024.