Dental CariesNCT02568917
Effectiveness of ART and Conventional Treatment - Practice-based Clinical Trial
A study testing Atraumatic Restorative Treatment - Ketac Molar Easy Mix and Conventional Restoration - Composite Resin (Bulk Fill) in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Atraumatic Restorative Treatment - Ketac Molar Easy Mix and Conventional Restoration - Composite Resin (Bulk Fill)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2020to Aug 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aging between 6 and 14 years
- presenting good health conditions
- spontaneous demand for treatment by parents or legal guardians
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary or permanent molars
- only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement
Who cannot join
- severe behavioral issues
- presence of fistula or abscess near the selected tooth
- presence of pulp exposure in the selected tooth
- presence of mobility in the selected tooth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial
Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.
Read the detailed description
Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.
Discussion: Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART presents superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers
Keywords: atraumatic restorative treatment, composite resin, glass ionomer cement, randomized clinical trial, cost effectiveness analysis
- Conditions
- Dental Caries
- Being tested
- Atraumatic Restorative Treatment - Ketac Molar Easy Mix, Conventional Restoration - Composite Resin (Bulk Fill)
- Keywords
- Dental Atraumatic Restorative Treatment, Composite Resins, Primary Teeth, Permanent Teeth, Clinical Effectiveness, Cost Analysis
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative Treatment - Ketac Molar Easy MixProcedure or surgery
Occlusal and occlusal-proximal ART restorations in primary and permanent molars using the high viscosity GIC Ketac Molar Easy mix will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
Conventional Restoration - Composite Resin (Bulk Fill)Procedure or surgery
Occlusal and occlusal-proximal composite resin restorations in primary and permanent molars using the Scotchbond Multi-purpose adhesive system and the Filtek Bulk Fill composite resin wil be performed. Local anesthesia can be used if necessary. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Restoration | Active comparator | Conventional Restoration - Composite Resin (Bulk Fill) Receives: Procedure: Conventional Restoration - Composite Resin (Bulk Fill) |
| Atraumatic Restorative Treatment | Experimental | Atraumatic Restorative Treatment - Ketac Molar Easy Mix Receives: Procedure: Atraumatic Restorative Treatment - Ketac Molar Easy Mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The restoration survival
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
Measured: Every 6 months up to 18 months
Secondary outcomes (2)
Longevity of the tooth
For evaluation of this outcome will be considered "successful" the restoration even a minor failure of the restoration (scores 00 to 30). Only the restored teeth that presents symptoms of pulp inflammation or need for extraction (scores 40 and 50) will be considered as "failure", since it cannot be considered as a successful treatment for the tooth.
The main objective of a restoration is to aprovide patient a condition for improved hygiene, can enable inactivation of injury, plus the return of the masticatory function of that tooth, so the scores considered "minor failures" is not considered failure for the tooth (Bonifácio et al., 2012).
Measured: Every 6 months up to 18 months
Cost-effectiveness assessment
Treatment costs will be calculated considering professional costs and procedure costs. In order to calculate the professional cost the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment ($36,23). On the other hand, to estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), we will consider their price, the lifespan of five years and a monthly use of 160 hours, using an estimate value per hour of $1,81. All materials used in each procedure will have their specifications and quantity registered. Prices will be inferences from the market value converted in US Dollars and obtained by the medium of the values from different places that commercialized the referred products.
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: There was a problem with the municipality and they have choose to suspend it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Prócida Raggio, University of Sao Paulo
- Investigators
- Daniela P Raggio, Professor, Principal investigator, University of Sao PauloIsabel C Olegário, PhD Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568917
- Sponsor's protocol ID
- EFFART
- Status last verified
- Jun 2020
- First submitted
- 29 Sep 2015
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olegario IC, Hesse D, Bonecker M, Imparato JC, Braga MM, Mendes FM, Raggio DP. Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial. BMC Oral Health. 2016 Aug 2;17(1):34. doi: 10.1186/s12903-016-0260-6.
PubMed 27485432
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Atraumatic Restorative Treatment and Conventional Restorations in Primary and Permanent Dentition: A Practice-based Clinical Trial
- ClinicalTrials.gov ID
- NCT02568917
- Acronym / sponsor ID
- EFFART
- Conditions
- Dental Caries
- Keywords
- Dental Atraumatic Restorative Treatment, Composite Resins, Primary Teeth, Permanent Teeth, Clinical Effectiveness, Cost Analysis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: There was a problem with the municipality and they have choose to suspend it.
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- 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.
Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.
Detailed description
Background: Dental caries is still a public health problem among Brazilian children and doubts still exist regarding the most effective restorative technique. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) in primary and permanent teeth.
Methods: A total of 1,214 5-to-13 years-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in the public schools of Barueri-SP. The participants will be randomly divided into 2 groups: CT (Filtek Bulk Fill - 3M) and ART (Ketac Molar Easy Mix - 3M) and treated by ten untrained dentists in a dental office inside the schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operator preference of the treatment regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied to the survival of restorations. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator cluster-effect. The significance level for all analyses will be 5%.
Discussion: Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART presents superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers
Keywords: atraumatic restorative treatment, composite resin, glass ionomer cement, randomized clinical trial, cost effectiveness analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Restoration | Active comparator | Procedure: Conventional Restoration - Composite Resin (Bulk Fill)Conventional Restoration - Composite Resin (Bulk Fill) |
| Atraumatic Restorative Treatment | Experimental | Procedure: Atraumatic Restorative Treatment - Ketac Molar Easy MixAtraumatic Restorative Treatment - Ketac Molar Easy Mix |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aging between 6 and 14 years
- presenting good health conditions
- spontaneous demand for treatment by parents or legal guardians
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary or permanent molars
Key exclusion criteria (4 listed)
- severe behavioral issues
- presence of fistula or abscess near the selected tooth
- presence of pulp exposure in the selected tooth
- presence of mobility in the selected tooth
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 - Ketac Molar Easy MixOcclusal and occlusal-proximal ART restorations in primary and permanent molars using the high viscosity GIC Ketac Molar Easy mix will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. | Procedure or surgery | Atraumatic Restorative Treatment |
| Conventional Restoration - Composite Resin (Bulk Fill)Occlusal and occlusal-proximal composite resin restorations in primary and permanent molars using the Scotchbond Multi-purpose adhesive system and the Filtek Bulk Fill composite resin wil be performed. Local anesthesia can be used if necessary. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked. | Procedure or surgery | Conventional Restoration |
Primary outcome
The restoration survival
Time frame: Every 6 months up to 18 months
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
2 secondary outcomes
Longevity of the tooth
Time frame: Every 6 months up to 18 months
Cost-effectiveness assessment
Time frame: Through study completion, an average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 27485432Olegario IC, Hesse D, Bonecker M, Imparato JC, Braga MM, Mendes FM, Raggio DP. Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial. BMC Oral Health. 2016 Aug 2;17(1):34. doi: 10.1186/s12903-016-0260-6.
- Individual participant dataSharing planned: No
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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.
Daniela P Raggio, Professor principal investigator
University of Sao Paulo
Isabel C Olegário, PhD Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment - Ketac Molar Easy Mix and Conventional Restoration - Composite Resin (Bulk Fill) in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 4 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: paused, as of the sponsor's last update on 12 Jun 2020. 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 Brazil. 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?
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?
The restoration survival (time frame: Every 6 months up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02568917, which also lists 1 linked publication.
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 12 Jun 2020.