Dental CariesNCT02730000
Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
A study testing ART with Equia and ART with Riva Self Cure in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- ART with Equia and ART with Riva Self Cure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Nov 2018
- 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
- Children aging between 4 and 8 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal proximal caries lesion in primary molars
- only 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
Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log-rank test. To evaluate the association between longevity and variable Cox regression test will be applied. For the cost analysis will be used analysis of variance.
Read the detailed description
Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7).
- Conditions
- Dental Caries
- Being tested
- ART with Equia, ART with Riva Self Cure
- Keywords
- Dental Atraumatic Restorative Treatment, Primary Teeth, Clinical Efficacy, Cost Analysis, Glass Ionomer Cement
- 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 with EquiaProcedure or surgery
Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) 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.
ART with Riva Self CureProcedure or surgery
Occlusal-proximal ART restorations in primary molars using Riva Self Cure 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.
| Study group | Role | What they receive |
|---|---|---|
| ART with Equia | Active comparator | Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling. Receives: Procedure: ART with Equia |
| ART with Riva Self Cure | Experimental | Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling. Receives: Procedure: ART with Riva Self Cure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longevity of atraumatic restoration
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" 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: up to 24 months
Secondary outcomes (1)
Cost-efficacy 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), the investigators 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: an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- 148 participants (actual)
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 Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730000
- Sponsor's protocol ID
- RIVAART
- Status last verified
- Nov 2018
- First submitted
- 22 Feb 2016
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bonifacio CC, Hesse D, de Oliveira Rocha R, Bonecker M, Raggio DP, van Amerongen WE. Survival rate of approximal-ART restorations using a two-layer technique for glass ionomer insertion. Clin Oral Investig. 2013 Sep;17(7):1745-50. doi: 10.1007/s00784-012-0859-1. Epub 2012 Oct 11.
PubMed 23053709Bonifacio CC, Kleverlaan CJ, Raggio DP, Werner A, de Carvalho RC, van Amerongen WE. Physical-mechanical properties of glass ionomer cements indicated for atraumatic restorative treatment. Aust Dent J. 2009 Sep;54(3):233-7. doi: 10.1111/j.1834-7819.2009.01125.x.
PubMed 19709111da Franca C, Colares V, Van Amerongen E. Two-year evaluation of the atraumatic restorative treatment approach in primary molars class I and II restorations. Int J Paediatr Dent. 2011 Jul;21(4):249-53. doi: 10.1111/j.1365-263X.2011.01125.x. Epub 2011 Mar 15.
PubMed 21401749de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
PubMed 21274581Deepa G, Shobha T. A clinical evaluation of two glass ionomer cements in primary molars using atraumatic restorative treatment technique in India: 1 year follow up. Int J Paediatr Dent. 2010 Nov;20(6):410-8. doi: 10.1111/j.1365-263X.2010.01067.x.
PubMed 20642467Dowling AH, Fleming GJ. Are encapsulated anterior glass-ionomer restoratives better than their hand-mixed equivalents? J Dent. 2009 Feb;37(2):133-40. doi: 10.1016/j.jdent.2008.10.006. Epub 2008 Dec 6.
PubMed 19059689Frencken JE, Van 't Hof MA, Van Amerongen WE, Holmgren CJ. Effectiveness of single-surface ART restorations in the permanent dentition: a meta-analysis. J Dent Res. 2004 Feb;83(2):120-3. doi: 10.1177/154405910408300207.
PubMed 14742648Gibson G, Jurasic MM, Wehler CJ, Jones JA. Supplemental fluoride use for moderate and high caries risk adults: a systematic review. J Public Health Dent. 2011 Summer;71(3):171-84.
PubMed 21972457Harris R, Gamboa A, Dailey Y, Ashcroft A. One-to-one dietary interventions undertaken in a dental setting to change dietary behaviour. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006540. doi: 10.1002/14651858.CD006540.pub2.
PubMed 22419315Holmgren CJ, Lo EC, Hu D, Wan H. ART restorations and sealants placed in Chinese school children--results after three years. Community Dent Oral Epidemiol. 2000 Aug;28(4):314-20. doi: 10.1034/j.1600-0528.2000.280410.x.
PubMed 10901411Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010 Oct;19(7):512-6. doi: 10.1111/j.1532-849X.2010.00628.x. Epub 2010 Aug 16.
PubMed 20723019Kemoli AM, van Amerongen WE. Influence of the cavity-size on the survival rate of proximal ART restorations in primary molars. Int J Paediatr Dent. 2009 Nov;19(6):423-30. doi: 10.1111/j.1365-263X.2009.01013.x. Epub 2009 Sep 1.
PubMed 19732191Kemoli AM, Opinya GN, van Amerongen WE, Mwalili SM. Two-year survival rates of proximal atraumatic restorative treatment restorations in relation to glass ionomer cements and Postrestoration meals consumed. Pediatr Dent. 2011 May-Jun;33(3):246-51.
PubMed 21703078Mickenautsch S, Yengopal V, Banerjee A. Atraumatic restorative treatment versus amalgam restoration longevity: a systematic review. Clin Oral Investig. 2010 Jun;14(3):233-40. doi: 10.1007/s00784-009-0335-8. Epub 2009 Aug 18.
PubMed 19688227van Duinen RN, Kleverlaan CJ, de Gee AJ, Werner A, Feilzer AJ. Early and long-term wear of 'fast-set' conventional glass-ionomer cements. Dent Mater. 2005 Aug;21(8):716-20. doi: 10.1016/j.dental.2004.09.007.
PubMed 16026667
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement
- ClinicalTrials.gov ID
- NCT02730000
- Acronym / sponsor ID
- RIVAART
- Conditions
- Dental Caries
- Keywords
- Dental Atraumatic Restorative Treatment, Primary Teeth, Clinical Efficacy, Cost Analysis, Glass Ionomer Cement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Apr 2016 (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.
Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log-rank test. To evaluate the association between longevity and variable Cox regression test will be applied. For the cost analysis will be used analysis of variance.
Detailed description
Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART with Equia | Active comparator | Procedure: ART with EquiaOcclusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling. |
| ART with Riva Self Cure | Experimental | Procedure: ART with Riva Self CureOcclusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aging between 4 and 8 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal proximal caries lesion in primary molars
- only 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 with EquiaOcclusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) 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 | ART with Equia |
| ART with Riva Self CureOcclusal-proximal ART restorations in primary molars using Riva Self Cure 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 | ART with Riva Self Cure |
Primary outcome
Longevity of atraumatic restoration
Time frame: up to 24 months
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" 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.
1 secondary outcome
Cost-efficacy assessment
Time frame: an average of 24 months
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 7 Nov 2018.
- Results publication: PubMed 23053709Bonifacio CC, Hesse D, de Oliveira Rocha R, Bonecker M, Raggio DP, van Amerongen WE. Survival rate of approximal-ART restorations using a two-layer technique for glass ionomer insertion. Clin Oral Investig. 2013 Sep;17(7):1745-50. doi: 10.1007/s00784-012-0859-1. Epub 2012 Oct 11.
- Results publication: PubMed 19709111Bonifacio CC, Kleverlaan CJ, Raggio DP, Werner A, de Carvalho RC, van Amerongen WE. Physical-mechanical properties of glass ionomer cements indicated for atraumatic restorative treatment. Aust Dent J. 2009 Sep;54(3):233-7. doi: 10.1111/j.1834-7819.2009.01125.x.
- Results publication: PubMed 21401749da Franca C, Colares V, Van Amerongen E. Two-year evaluation of the atraumatic restorative treatment approach in primary molars class I and II restorations. Int J Paediatr Dent. 2011 Jul;21(4):249-53. doi: 10.1111/j.1365-263X.2011.01125.x. Epub 2011 Mar 15.
- Results publication: PubMed 21274581de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
- Results publication: PubMed 20642467Deepa G, Shobha T. A clinical evaluation of two glass ionomer cements in primary molars using atraumatic restorative treatment technique in India: 1 year follow up. Int J Paediatr Dent. 2010 Nov;20(6):410-8. doi: 10.1111/j.1365-263X.2010.01067.x.
- Results publication: PubMed 19059689Dowling AH, Fleming GJ. Are encapsulated anterior glass-ionomer restoratives better than their hand-mixed equivalents? J Dent. 2009 Feb;37(2):133-40. doi: 10.1016/j.jdent.2008.10.006. Epub 2008 Dec 6.
- Results publication: PubMed 14742648Frencken JE, Van 't Hof MA, Van Amerongen WE, Holmgren CJ. Effectiveness of single-surface ART restorations in the permanent dentition: a meta-analysis. J Dent Res. 2004 Feb;83(2):120-3. doi: 10.1177/154405910408300207.
- Results publication: PubMed 21972457Gibson G, Jurasic MM, Wehler CJ, Jones JA. Supplemental fluoride use for moderate and high caries risk adults: a systematic review. J Public Health Dent. 2011 Summer;71(3):171-84.
- Results publication: PubMed 22419315Harris R, Gamboa A, Dailey Y, Ashcroft A. One-to-one dietary interventions undertaken in a dental setting to change dietary behaviour. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006540. doi: 10.1002/14651858.CD006540.pub2.
- Results publication: PubMed 10901411Holmgren CJ, Lo EC, Hu D, Wan H. ART restorations and sealants placed in Chinese school children--results after three years. Community Dent Oral Epidemiol. 2000 Aug;28(4):314-20. doi: 10.1034/j.1600-0528.2000.280410.x.
- Results publication: PubMed 20723019Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010 Oct;19(7):512-6. doi: 10.1111/j.1532-849X.2010.00628.x. Epub 2010 Aug 16.
- Results publication: PubMed 19732191Kemoli AM, van Amerongen WE. Influence of the cavity-size on the survival rate of proximal ART restorations in primary molars. Int J Paediatr Dent. 2009 Nov;19(6):423-30. doi: 10.1111/j.1365-263X.2009.01013.x. Epub 2009 Sep 1.
- 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
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 with Equia and ART with Riva Self Cure 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: finished, as of the sponsor's last update on 7 Nov 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?
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?
Longevity of atraumatic restoration (time frame: 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 NCT02730000, which also lists 25 linked publications.
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 Nov 2018.