Dental CariesNCT05538559
Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth
A study testing Chemomechanical caries removal by Carie-Care and Mechanical caries removal by Atraumatic Restorative Technique in people with Dental Caries and Primary Teeth, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth… Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Caries, Primary Teeth
- What is being tested?
- Chemomechanical caries removal by Carie-Care and Mechanical caries removal by Atraumatic Restorative Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 30 Oct 2022
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System[ICDAS].
- The access of the carious lesion has to be large enough to allow the penetration of the excavator
- Children with behavior rating 3 or 4 according to the Frankl scale
Who cannot join
- Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
- Proximal caries evidenced by bitewing x-ray
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Alaa Y Ghanem, BDS, 01020208494, Alaaghanem952@gmail.com
About this study
Official title: The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)
Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure
- Conditions
- Dental Caries, Primary Teeth
- Being tested
- Chemomechanical caries removal by Carie-Care, Mechanical caries removal by Atraumatic Restorative Technique
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemomechanical caries removal by Carie-CareOther
caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.
Mechanical caries removal by Atraumatic Restorative TechniqueOther
caries in primary teeth will be removed using the mechanical caries removal by ART method.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Not described Receives: Other: Chemomechanical caries removal by Carie-Care |
| Control | Active comparator | Not described Receives: Other: Mechanical caries removal by Atraumatic Restorative Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for caries removal
The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.
Measured: Through procedure completion
Efficacy of caries removal
Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity
Measured: Through procedure completion
Child pain perception
The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)
Measured: Through procedure completion
Child behavior
Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation.
Score 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively.
Score 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn.
Score 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.
Measured: Through procedure completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Jun 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538559
- Sponsor's protocol ID
- Caries Removal 2022
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05538559
- Acronym / sponsor ID
- Caries Removal 2022
- Conditions
- Dental Caries, Primary Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 14 Sep 2022 (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.
Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Other: Chemomechanical caries removal by Carie-Care |
| Control | Active comparator | Other: Mechanical caries removal by Atraumatic Restorative Technique |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System[ICDAS].
- The access of the carious lesion has to be large enough to allow the penetration of the excavator
- Children with behavior rating 3 or 4 according to the Frankl scale
Key exclusion criteria (2 listed)
- Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
- Proximal caries evidenced by bitewing x-ray
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 |
|---|---|---|
| Chemomechanical caries removal by Carie-Carecaries in primary teeth will be removed using Carie-Care™ the chemomechanical agent. | Other | Test |
| Mechanical caries removal by Atraumatic Restorative Techniquecaries in primary teeth will be removed using the mechanical caries removal by ART method. | Other | Control |
Primary outcome
Time taken for caries removal
Time frame: Through procedure completion
The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.
Efficacy of caries removal
Time frame: Through procedure completion
Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity
Child pain perception
Time frame: Through procedure completion
The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)
Child behavior
Time frame: Through procedure completion
Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation. Score 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. Score 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn. Score 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemomechanical caries removal by Carie-Care and Mechanical caries removal by Atraumatic Restorative Technique in people with Dental Caries and Primary Teeth, run by Hams Hamed Abdelrahman 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 2 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 14 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Y Ghanem, BDS (01020208494, Alaaghanem952@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken for caries removal (time frame: Through procedure completion). The study lists 4 primary outcomes in all. 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 14 Sep 2022.