Dental Caries in Primary Molars in ChildrenNCT07857785
Comparison of Smart Burs , Atraumatic Restorative Treatment and Gentle Hand Burs for Caries Removal in Children
A study testing Gentle Hand Burs, Atraumatic Restorative Treatment and Smart Burs(polymer bur) in people with Dental Caries in Primary Molars in Children, run by Sathiraju Hema Sai Niharika at 1 site in India.
Trial summary
This study compared three gentle ways of removing tooth decay in children's primary molars:Gentle hand burs(new hand held rotary instrument used withot electricity),Smart burs (polymer burs used in a slow speed hand piece) and Atraumatic Restorative Treatment(removal with hand spoon excavator).Ninety children aged… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Dental Caries in Primary Molars in Children
- What is being tested?
- Gentle Hand Burs, Atraumatic Restorative Treatment and Smart Burs(polymer bur)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 17 Oct 2023to 30 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5 to 11 years
- Atleast one active carious lesion on the occlusal surface of an asymptomatic primary molar
- ICDAS score 4 to 6
- Radiographic evidence of enamel and dentin involvement without pulpal involvement.
- Written consent form from parent/guardian of child. -
Who cannot join
- 1)Pulpal exposure or bleeding during excavation 2)Tenderness to percussion 3)Non vital or grossly decayed teeth 4)Devlopmental anomalies such as fusion,gemination,dilaceration or amelogenesis imperfecta.
- -
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Paediatric and Preventive Dentistry,Meghna Institute of Dental Sciences
Nizāmābād, Telangana, 503001
About this study
Official title: Comparative Evaluation of Smart Burs,Atraumatic Restorative Treatment and Gentle Hand Burs for Caries Removal in Paediatric Patients: Randomised Controlled Study
This study compared three gentle ways of removing tooth decay in children's primary molars:Gentle hand burs(new hand held rotary instrument used withot electricity),Smart burs (polymer burs used in a slow speed hand piece) and Atraumatic Restorative Treatment(removal with hand spoon excavator).Ninety children aged 5-11 years with a decayed occlusal surface on a primary molar were randomly assigned to one of the three methods.The study measured how completly decay was removed,how long removal took,how anxious the child was during treatment and how much pain the child reported afterwards.
Read the detailed description
Conventional high speed rotary caries removal can remove sound tooth structure,generate heat and aerosols and cause anxiety in children due to noise and vibration.Minimally invasive alternatives include Atraumatic Restorative Treament(ART) using hand excavators,self limiting polymer smart burs,and the recentl introduced Gentle Hand Burs ,which have an aluminium handle and long-shank carbide bur and need no electricity.
This single center,parallel group,randomised controlled trial was conducted in the Department of paediatric and preventive dentistry,Meghna Institute of Dental sciences,Mallaram,Nizamabad,Telangana,India.Ninety children aged 5-11 years with occlusal caries lesions {ICDAS 4-6} in asymptomatic primary molars without pulpal involvement were allocated 1:1:1 by lottery method to ART,Gentle Hand Burs or Smart burs(30 per group).Sample size were calculated with alpha 0.05 and power 95%.
Under rubber dam isolation, a caries-indicator dye was applied for 10 seconds and rinsed .Caries was removed by a single operator ; the end point was no catch with a straight explorer and no dye staining.Efficacy was scored with ericson's criteria,time was recorded,behaviour was rated by two examiners with the Sound,Eye,Motor(SEM) scale, and pain was self reported with the Wong Baker FACES Scale after treatment.Glass Ionomer Cement Restoration placed after excavation.
- Being tested
- Gentle Hand Burs, Atraumatic Restorative Treatment, Smart Burs(polymer bur)
- Keywords
- Atraumatic Restorative Treatment,Gentle Hand Burs,Smart Burs,Minimally Invasive Dentistry,Primary Molar Caries removal,Paediatric Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Hand BursDevice
Caries removal done by manually operated instrument which is an aluminium handle and long shank carbide bur,without electricity or handpiece( Gerry Bueachmin,USA).
Atraumatic Restorative TreatmentProcedure or surgery
Caries removal with sharp spoon excavator without rotary instruments.
Smart Burs(polymer bur)Device
Self limiting polymer bur used in a slowspeed contra angle hand piece ,replaced when blunted.
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment(ART) | Active comparator | Caries removed with a spoon excavator in a scooping motion.Under rubber dam isolation a caries indicator dye (Reveal) was applied and at the end point was no catch with an explorer and no dye staining.Glass Ionomer Cement was placed afterwads. Receives: Procedure: Atraumatic Restorative Treatment |
| Smart Burs | Active comparator | Caries removed with a self limiting polymer Smart bur (Smart Burs II,Boston) in a slow speed contra angle hand piece,working from cavity outward.For every arm under rubber dam isolation a caries indicator dye was applied and the end point was no catch with an explorer and no dye staining.The ,Glass Ionomer Cement was placed. Receives: Device: Smart Burs(polymer bur) |
| Gentle Hand Burs | Experimental | Caries removed with Gentle hand burs used manually in circular direction.Under rubbe dam isolation , a caries indicator dye was applied andend point was no catch with an explorer and no dye staing.Glass Ionomer Cement was placed. Receives: Device: Gentle Hand Burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for caries removal (efficiency)
Time in minutes from the start of excavation to the clinical end-point ( no catch with explorer and no dye staining ), recorded with a stopwatch.
Measured: During the procedure (single visit)
Efficacy of caries removal
Completeness of caries removal scored with Ericson's criteria (0 to 5;0=caries completly removed).
Measured: Immediately after excavation (single visit)
Secondary outcomes (2)
Child behaviour during treatment
Sound,Eye,Motor (SEM) scale scores recorded by two calibrated examiners; higher scores mean more discomfort.
Measured: During the procedure (single visit).
Pain perception
Wong Baker FACES Pain Rating Scale (0 to 10) self reported by the child;higher scores mean more pain.
Measured: Immediately after the procedure( sinle visit ).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start17 Oct 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in Primary Molars 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sathiraju Hema Sai Niharika
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sathiraju Hema Sai Niharika, Meghna Institute of Dental Sciences
- Investigators
- Sathiraju Hema Sai Niharika post graduate in paediatric and preventive dentistry, MDS, Principal investigator, Meghna Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857785
- Sponsor's protocol ID
- MIDS/MDS/PEDO/2022-23
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indiviual participant data will not be shared publicly; de-identified data are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Smart Burs,Atraumatic Restorative Treatment and Gentle Hand Burs for Caries Removal in Paediatric Patients: Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07857785
- Acronym / sponsor ID
- MIDS/MDS/PEDO/2022-23
- Keywords
- Atraumatic Restorative Treatment,Gentle Hand Burs,Smart Burs,Minimally Invasive Dentistry,Primary Molar Caries removal,Paediatric Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sathiraju Hema Sai NiharikaUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Oct 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.
This study compared three gentle ways of removing tooth decay in children's primary molars:Gentle hand burs(new hand held rotary instrument used withot electricity),Smart burs (polymer burs used in a slow speed hand piece) and Atraumatic Restorative Treatment(removal with hand spoon excavator).Ninety children aged 5-11 years with a decayed occlusal surface on a primary molar were randomly assigned to one of the three methods.The study measured how completly decay was removed,how long removal took,how anxious the child was during treatment and how much pain the child reported afterwards.
Detailed description
Conventional high speed rotary caries removal can remove sound tooth structure,generate heat and aerosols and cause anxiety in children due to noise and vibration.Minimally invasive alternatives include Atraumatic Restorative Treament(ART) using hand excavators,self limiting polymer smart burs,and the recentl introduced Gentle Hand Burs ,which have an aluminium handle and long-shank carbide bur and need no electricity.
This single center,parallel group,randomised controlled trial was conducted in the Department of paediatric and preventive dentistry,Meghna Institute of Dental sciences,Mallaram,Nizamabad,Telangana,India.Ninety children aged 5-11 years with occlusal caries lesions {ICDAS 4-6} in asymptomatic primary molars without pulpal involvement were allocated 1:1:1 by lottery method to ART,Gentle Hand Burs or Smart burs(30 per group).Sample size were calculated with alpha 0.05 and power 95%.
Under rubber dam isolation, a caries-indicator dye was applied for 10 seconds and rinsed .Caries was removed by a single operator ; the end point was no catch with a straight explorer and no dye staining.Efficacy was scored with ericson's criteria,time was recorded,behaviour was rated by two examiners with the Sound,Eye,Motor(SEM) scale, and pain was self reported with the Wong Baker FACES Scale after treatment.Glass Ionomer Cement Restoration placed after excavation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment(ART) | Active comparator | Procedure: Atraumatic Restorative TreatmentCaries removed with a spoon excavator in a scooping motion.Under rubber dam isolation a caries indicator dye (Reveal) was applied and at the end point was no catch with an explorer and no dye staining.Glass Ionomer Cement was placed afterwads. |
| Smart Burs | Active comparator | Device: Smart Burs(polymer bur)Caries removed with a self limiting polymer Smart bur (Smart Burs II,Boston) in a slow speed contra angle hand piece,working from cavity outward.For every arm under rubber dam isolation a caries indicator dye was applied and the end point was no catch with an explorer and no dye staining.The ,Glass Ionomer Cement was placed. |
| Gentle Hand Burs | Experimental | Device: Gentle Hand BursCaries removed with Gentle hand burs used manually in circular direction.Under rubbe dam isolation , a caries indicator dye was applied andend point was no catch with an explorer and no dye staing.Glass Ionomer Cement was placed. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5 to 11 years
- Atleast one active carious lesion on the occlusal surface of an asymptomatic primary molar
- ICDAS score 4 to 6
- Radiographic evidence of enamel and dentin involvement without pulpal involvement.
- Written consent form from parent/guardian of child. -
Key exclusion criteria (2 listed)
- 1)Pulpal exposure or bleeding during excavation 2)Tenderness to percussion 3)Non vital or grossly decayed teeth 4)Devlopmental anomalies such as fusion,gemination,dilaceration or amelogenesis imperfecta.
- -
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 |
|---|---|---|
| Gentle Hand BursCaries removal done by manually operated instrument which is an aluminium handle and long shank carbide bur,without electricity or handpiece( Gerry Bueachmin,USA). | Device | Gentle Hand Burs |
| Atraumatic Restorative TreatmentCaries removal with sharp spoon excavator without rotary instruments. | Procedure or surgery | Atraumatic Restorative Treatment(ART) |
| Smart Burs(polymer bur)Self limiting polymer bur used in a slowspeed contra angle hand piece ,replaced when blunted. | Device | Smart Burs |
Primary outcome
Time taken for caries removal (efficiency)
Time frame: During the procedure (single visit)
Time in minutes from the start of excavation to the clinical end-point ( no catch with explorer and no dye staining ), recorded with a stopwatch.
Efficacy of caries removal
Time frame: Immediately after excavation (single visit)
Completeness of caries removal scored with Ericson's criteria (0 to 5;0=caries completly removed).
2 secondary outcomes
Child behaviour during treatment
Time frame: During the procedure (single visit).
Pain perception
Time frame: Immediately after the procedure( sinle visit ).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Indiviual participant data will not be shared publicly; de-identified data are available from the principal investigator on reasonable request.
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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.
Sathiraju Hema Sai Niharika post graduate in paediatric and preventive dentistry, MDS principal investigator
Meghna Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Hand Burs, Atraumatic Restorative Treatment and Smart Burs(polymer bur) in people with Dental Caries in Primary Molars in Children, run by Sathiraju Hema Sai Niharika at 1 site in India.
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 5 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: finished, as of the sponsor's last update on 5 Oct 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time taken for caries removal (efficiency) (time frame: During the procedure (single visit)). The study lists 2 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 5 Oct 2026.