Dental Caries in ChildrenNCT05529433
Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars
A study testing Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-Mechanical Caries Removal (CMCR) in people with Dental Caries in Children, run by Cairo University.
Trial summary
The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars. 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?
- Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-Mechanical Caries Removal (CMCR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Feb 2023
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Caries in second primary molars within enamel/ dentin without pulp disease.
- There is a clear band of dentin coronal.
- Cooperative and healthy children.
Who cannot join
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of spontaneous pain.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) 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.
In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.
Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.
Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.
Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.
- Conditions
- Dental Caries in Children
- Being tested
- Atraumatic Restorative Treatment (ART), Smart Burs, Chemo-Mechanical Caries Removal (CMCR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative Treatment (ART)Procedure or surgery
Atraumatic Restorative Treatment is highly accepted by the patients as there is no need for local anesthesia. It is a minimal invasive technique which preserves sound tooth structure as caries removal will be done by a sharp spoon excavator. It requires less time during caries removal. There is a chemical bond between the tooth and the glass ionomer adhesive material. So, there is no need for cutting sound tooth structure for retention of the restoration.
Smart BursProcedure or surgery
Smart Bur is a polymer bur which removes only soft infected dentin as the cutting edges become dull in contact with the hard affected dentin.Caries removal will be done by Smart Bur mounted on a low speed hand-piece leaving the affected dentin intact. It requires less time for caries removal.
Chemo-Mechanical Caries Removal (CMCR)Procedure or surgery
Also called Selecti-Solve gel (Denta Pharma, Egypt)
Selecti-Solve gel is a dental gel which main active ingredient is Papain enzyme which selectively removes the caries without pain and has bacteriostatic, bactericidal and anti-inflammatory properties. The use of CMCR is recommended as an alternative treatment technique in anxious patients. The gel will be applied with a blunt spoon instrument and distributed well into the cavity according to manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment (ART) | Active comparator | Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort. Receives: Procedure: Atraumatic Restorative Treatment (ART) |
| Smart Burs | Experimental | Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin. Receives: Procedure: Smart Burs |
| Chemo-Mechanical Caries Removal (CMCR) | Experimental | A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling. Receives: Procedure: Chemo-Mechanical Caries Removal (CMCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
The pain will be assessed by Visual Analogue Scale (VAS)
Measured: at baseline
Secondary outcomes (2)
Time taken for caries removal
The time is measured by a stopwatch in minutes
Measured: at baseline
Efficacy of caries removal
The efficacy of caries removal will be assessed by Caries Detector dye.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (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.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Mahmoud Abdel Sattar El sayed, Cairo University
- Investigators
- Rania Nasr, Professor, Study director, Cairo UniversityRasha Hatem, Associate Professor, Study director, Cairo UniversityReham Mahmoud, BDS, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529433
- Sponsor's protocol ID
- b9xe7bsh
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05529433
- Acronym / sponsor ID
- b9xe7bsh
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 7 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.
The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) 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.
In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.
Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.
Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.
Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment (ART) | Active comparator | Procedure: Atraumatic Restorative Treatment (ART)Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort. |
| Smart Burs | Experimental | Procedure: Smart BursSmart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin. |
| Chemo-Mechanical Caries Removal (CMCR) | Experimental | Procedure: Chemo-Mechanical Caries Removal (CMCR)A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Caries in second primary molars within enamel/ dentin without pulp disease.
- There is a clear band of dentin coronal.
- Cooperative and healthy children.
Key exclusion criteria (3 listed)
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of spontaneous pain.
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 |
|---|---|---|
| Atraumatic Restorative Treatment (ART)Atraumatic Restorative Treatment is highly accepted by the patients as there is no need for local anesthesia. It is a minimal invasive technique which preserves sound tooth structure as caries removal will be done by a sharp spoon excavator. It requires less time during caries removal. There is a chemical bond between the tooth and the glass ionomer adhesive material. So, there is no need for cutting sound tooth structure for retention of the restoration. | Procedure or surgery | Atraumatic Restorative Treatment (ART) |
| Smart BursSmart Bur is a polymer bur which removes only soft infected dentin as the cutting edges become dull in contact with the hard affected dentin.Caries removal will be done by Smart Bur mounted on a low speed hand-piece leaving the affected dentin intact. It requires less time for caries removal. | Procedure or surgery | Smart Burs |
| Chemo-Mechanical Caries Removal (CMCR)Also: Selecti-Solve gel (Denta Pharma, Egypt)Selecti-Solve gel is a dental gel which main active ingredient is Papain enzyme which selectively removes the caries without pain and has bacteriostatic, bactericidal and anti-inflammatory properties. The use of CMCR is recommended as an alternative treatment technique in anxious patients. The gel will be applied with a blunt spoon instrument and distributed well into the cavity according to manufacturer's instructions. | Procedure or surgery | Chemo-Mechanical Caries Removal (CMCR) |
Primary outcome
Pain assessment
Time frame: at baseline
The pain will be assessed by Visual Analogue Scale (VAS)
2 secondary outcomes
Time taken for caries removal
Time frame: at baseline
Efficacy of caries removal
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Rania Nasr, Professor study director
Cairo University
Rasha Hatem, Associate Professor study director
Cairo University
Reham Mahmoud, BDS principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-Mechanical Caries Removal (CMCR) in people with Dental Caries in Children, run by Cairo University.
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 3 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 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Reham Mahmoud, BDS (+201117892999, reham_mahmoud@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 assessment (time frame: at baseline). 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 7 Sep 2022.