Dental Caries in ChildrenNCT06759311
Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth
A study testing ART, Brix 3000 and Carie Move in people with Dental Caries in Children, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- ART, Brix 3000 and Carie Move
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 20 Feb 2025
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Each child has three teeth with carious cavity enough for insertion of hand instruments
- Positive or definitely positive child behaviour according to the Frankl Behaviour Scale (FBS)
- Caries lesion in dentin of primary teeth
Who cannot join
- Negative" or "definitely negative" child behaviour according to the FBS.
- Presence of sign and symptoms of pulp lesion
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
Alexandria
About this study
Official title: Clinical Assessment of Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth (Randomized Control Clinical Trial)
Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment (ART), chemo-mechanical caries removal and smart bur.
- Conditions
- Dental Caries in Children
- Being tested
- ART, Brix 3000, Carie Move, Smart Bur
- Keywords
- Minimal Invasive Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTOther
The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin
Brix 3000Other
Brix 3000 gel will be applied to the caries lesion using a spoon excavator** leaving gel according to the manufacturer's instructions. After 2 minutes, the gel will turn from translucent green colour to cloudy after the gel removal.
Carie MoveOther
Carie-Move gel will be applied to the caries lesion according to the manufacturer's instructions at second visit in the same child. After 30 second the gel will be removed.
Smart BurOther
Removal of carious dentin will be carried out employing smart bur II mounted on a low-speed handpiece without water spray. Caries removal will be proceeded until the smart bur II becomes dull after repeated contact with healthy dentin (21) (figure 3)
| Study group | Role | What they receive |
|---|---|---|
| ART | Active comparator | Not described Receives: Other: ART |
| Brix 3000 | Experimental | Not described Receives: Other: Brix 3000 |
| Carie Move | Experimental | Not described Receives: Other: Carie Move |
| Smart Bur | Experimental | Not described Receives: Other: Smart Bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
Wong-Baker Faces Pain Rating Scale (WBFPS) Presents 6 faces with increasing degrees of pain from left to right. Each face was attributed a scale from 0 to 10 indicated onthe scale.
Children were asked to choose the face that best describe his or her pain.
Measured: Immediately after the intervention
caries removal time
The total working time required for caries removal will be recorded in minutes using a stopwatch
Measured: During procedure
Caries removal efficacy
The caries removal criteria:
0 Caries removed completely
- Caries noticed at the base of the cavity
- Caries noticed at the base and/or one wall of the cavity
- Caries noticed at the base and/or two walls of the cavity
- Caries noticed at the base and/or more than two walls of the cavity
- Caries noticed at the base, walls and margins of the cavity.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 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
- NCT06759311
- Sponsor's protocol ID
- 235-25-08-2024
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 6 Jan 2025
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth (Randomized Control Clinical Trial)
- ClinicalTrials.gov ID
- NCT06759311
- Acronym / sponsor ID
- 235-25-08-2024
- Conditions
- Dental Caries in Children
- Keywords
- Minimal Invasive Dentistry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 6 Jan 2025 (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.
Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment (ART), chemo-mechanical caries removal and smart bur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART | Active comparator | Other: ART |
| Brix 3000 | Experimental | Other: Brix 3000 |
| Carie Move | Experimental | Other: Carie Move |
| Smart Bur | Experimental | Other: Smart Bur |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Each child has three teeth with carious cavity enough for insertion of hand instruments
- Positive or definitely positive child behaviour according to the Frankl Behaviour Scale (FBS)
- Caries lesion in dentin of primary teeth
Key exclusion criteria (2 listed)
- Negative" or "definitely negative" child behaviour according to the FBS.
- Presence of sign and symptoms of pulp lesion
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 |
|---|---|---|
| ARTThe restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin | Other | ART |
| Brix 3000Brix 3000 gel will be applied to the caries lesion using a spoon excavator** leaving gel according to the manufacturer's instructions. After 2 minutes, the gel will turn from translucent green colour to cloudy after the gel removal. | Other | Brix 3000 |
| Carie MoveCarie-Move gel will be applied to the caries lesion according to the manufacturer's instructions at second visit in the same child. After 30 second the gel will be removed. | Other | Carie Move |
| Smart BurRemoval of carious dentin will be carried out employing smart bur II mounted on a low-speed handpiece without water spray. Caries removal will be proceeded until the smart bur II becomes dull after repeated contact with healthy dentin (21) (figure 3) | Other | Smart Bur |
Primary outcome
pain scores
Time frame: Immediately after the intervention
Wong-Baker Faces Pain Rating Scale (WBFPS) Presents 6 faces with increasing degrees of pain from left to right. Each face was attributed a scale from 0 to 10 indicated onthe scale. Children were asked to choose the face that best describe his or her pain.
caries removal time
Time frame: During procedure
The total working time required for caries removal will be recorded in minutes using a stopwatch
Caries removal efficacy
Time frame: Immediately after the intervention
The caries removal criteria: 0 Caries removed completely 1. Caries noticed at the base of the cavity 2. Caries noticed at the base and/or one wall of the cavity 3. Caries noticed at the base and/or two walls of the cavity 4. Caries noticed at the base and/or more than two walls of the cavity 5. Caries noticed at the base, walls and margins of the cavity.
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 6 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART, Brix 3000 and Carie Move in people with Dental Caries in Children, 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores (time frame: Immediately after the intervention). The study lists 3 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 6 Jan 2025.