Dental CariesNCT02562456
Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars
A study testing ART using Fuji IX and Conventional Treatment in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- ART using Fuji IX and Conventional Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2015to 10 Dec 2019
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aging between 3 and 6 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary 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.
Brazil1 site
Complexo Educacional Carlos Osmarinho de Lima - Trailer USP
Barueri, São Paulo
About this study
Official title: Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.
Read the detailed description
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.
Randomization
The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.
Allocation concealment
To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.
Blinding
Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.
Operators
All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.
- Conditions
- Dental Caries
- Being tested
- ART using Fuji IX, Conventional Treatment
- Keywords
- Dental Atraumatic Restorative Treatment, Composite Resins, Primary Teeth, Clinical Efficacy, 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.
ART using Fuji IXProcedure or surgery
Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
Conventional TreatmentProcedure or surgery
Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Removal of unsupported enamel will be performed using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid 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. an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350) Receives: Procedure: Conventional Treatment |
| ART using Fuji IX | Experimental | Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX Receives: Procedure: ART using Fuji IX |
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 24 months.
Secondary outcomes (3)
Cost-efficacy assessment
Treatment costs = professional costs + procedure costs.
- Professional cost: the time spent in each session will be converted in hours and multiplied not only by the medium income of the dentist per hour added 40% of dangerousness but also by the medium income of a dental assistant added 20% of insalubrity
- Procedure cost: variable cost (equipment \& instruments depreciation and electricity) and and materials cost. To calculate the equipments' and instruments' depreciation, we will consider their price, the lifespan of 5 and 3 years respectively and a monthly use of 160 hours. To calculate materials' costs, 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 obtained by the medium of the values from different places that commercialized the referred products.
If the restorative treatment requires repairs, the additional cost of it will also be considered.
Measured: Through study completion, an average of 24 months
Child self-reported discomfort
The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he or she felt during the treatment. This answer should be given solely by the child, which means, no parental or professional interferences. The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session.
Measured: Immediately after treatment
Cooperation
Cooperation will be evaluated by the operator immediately after the end of the treatment using a 5-point scale: 1- Good behaviour, 2- Reasonable behaviour, 3- Indiferent, 4- Bad behaviour, 5- Really bad behaviour.
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start1 Nov 2015
- Primary completion10 Jun 2018
- Study completion10 Dec 2019 (estimated)
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
- 428 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, PhD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562456
- Sponsor's protocol ID
- RECART
- Status last verified
- Dec 2018
- First submitted
- 21 Sep 2015
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ladewig NM, Sahiara CS, Yoshioka L, Olegario IC, Floriano I, Tedesco TK, Mendes FM, Braga MM, Raggio DP. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 10;7(7):e015542. doi: 10.1136/bmjopen-2016-015542.
PubMed 28698331
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02562456
- Acronym / sponsor ID
- RECART
- Conditions
- Dental Caries
- Keywords
- Dental Atraumatic Restorative Treatment, Composite Resins, Primary Teeth, Clinical Efficacy, Cost Analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 29 Sep 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.
The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.
Detailed description
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.
Randomization
The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.
Allocation concealment
To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.
Blinding
Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.
Operators
All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Procedure: Conventional TreatmentOcclusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350) |
| ART using Fuji IX | Experimental | Procedure: ART using Fuji IXOcclusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aging between 3 and 6 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary molars
- only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement
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 |
|---|---|---|
| ART using Fuji IXOcclusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour. | Procedure or surgery | ART using Fuji IX |
| Conventional TreatmentOcclusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Removal of unsupported enamel will be performed using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid 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. an adapted matrix strip with a wooden wedge will be used to assure appropriate contour. | Procedure or surgery | Conventional Treatment |
Primary outcome
The restoration survival
Time frame: Every 6 months up to 24 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.
3 secondary outcomes
Cost-efficacy assessment
Time frame: Through study completion, an average of 24 months
Child self-reported discomfort
Time frame: Immediately after treatment
Cooperation
Time frame: Immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Derived from this study: PubMed 28698331Ladewig NM, Sahiara CS, Yoshioka L, Olegario IC, Floriano I, Tedesco TK, Mendes FM, Braga MM, Raggio DP. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 10;7(7):e015542. doi: 10.1136/bmjopen-2016-015542.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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, PhD study chair
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 ART using Fuji IX and Conventional Treatment 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 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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 24 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 NCT02562456, 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 11 Dec 2018.