Dental CariesNCT04491981
Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial
A study testing Encapsulated Glass Ionomer Cement and Composite resin in people with Dental Caries and Dental Caries in Children, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Dental Caries, Dental Caries in Children
- What is being tested?
- Encapsulated Glass Ionomer Cement and Composite resin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2021to 1 Aug 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who have sought treatment in the School of Dentistry, University of Sao Paulo
- Children between 3 and 10 years old
- Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth
Who cannot join
- Children whose parents did not agree to participate in the study
- Children with behavioural issues at the initial exam or who did not assent to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - School of Dentistry
São Paulo, 05508-000
Daniela P Raggio, Professor, + 55 11 976922202, danielar@usp.br
About this study
Official title: Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).
Read the detailed description
Failed restorations in primary teeth will be repaired using GIC or composite resin.
- Conditions
- Dental Caries, Dental Caries in Children
- Being tested
- Encapsulated Glass Ionomer Cement, Composite resin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated Glass Ionomer CementProcedure or surgery
Repair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement).
Composite resinProcedure or surgery
Repair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin).
| Study group | Role | What they receive |
|---|---|---|
| Encapsulated Glass Ionomer Cement | Experimental | Repair of restorations in primary molars using a high viscosity glass ionomer cement (RIVA Self Cure - SDI) Receives: Procedure: Encapsulated Glass Ionomer Cement |
| Composite resin | Experimental | Repair of restorations in primary molars using a composite resin (Filtek Bulk Fill- 3M ESPE) Receives: Procedure: Composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success of restorations after repair
Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations
Measured: 24 months
Secondary outcomes (2)
Cost- effectiveness of restorations repairs
To assess this outcome measure we will consider the percentage of patients needing new operatory interventions and costs will be assessed in monetary units (US dollars)
Measured: 24 months
Patient's discomfort
Wong-Baker facial scale - from 0 to 5 (immediately after treatment)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jul 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- None (open label)
- Enrolment
- 312 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, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491981
- Sponsor's protocol ID
- REPAIRC3
- Status last verified
- Apr 2021
- First submitted
- 15 Jun 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Opdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, Gaengler P, Lindberg A, Huysmans MC, van Dijken JW. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):943-9. doi: 10.1177/0022034514544217. Epub 2014 Jul 21.
PubMed 25048250Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.
PubMed 25100406Gordan VV, Riley JL 3rd, Blaser PK, Mondragon E, Garvan CW, Mjor IA. Alternative treatments to replacement of defective amalgam restorations: results of a seven-year clinical study. J Am Dent Assoc. 2011 Jul;142(7):842-9. doi: 10.14219/jada.archive.2011.0274.
PubMed 21719808Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.
PubMed 24907560Casagrande L, Laske M, Bronkhorst EM, Huysmans MCDNJM, Opdam NJM. Repair may increase survival of direct posterior restorations - A practice based study. J Dent. 2017 Sep;64:30-36. doi: 10.1016/j.jdent.2017.06.002. Epub 2017 Jun 8.
PubMed 28602850Kanzow P, Wiegand A, Gostemeyer G, Schwendicke F. Understanding the management and teaching of dental restoration repair: Systematic review and meta-analysis of surveys. J Dent. 2018 Feb;69:1-21. doi: 10.1016/j.jdent.2017.09.010. Epub 2017 Sep 21.
PubMed 28943362Qvist V, Poulsen A, Teglers PT, Mjor IA. The longevity of different restorations in primary teeth. Int J Paediatr Dent. 2010 Jan;20(1):1-7. doi: 10.1111/j.1365-263X.2009.01017.x.
PubMed 20059587Dias AGA, Magno MB, Delbem ACB, Cunha RF, Maia LC, Pessan JP. Clinical performance of glass ionomer cement and composite resin in Class II restorations in primary teeth: A systematic review and meta-analysis. J Dent. 2018 Jun;73:1-13. doi: 10.1016/j.jdent.2018.04.004. Epub 2018 Apr 9.
PubMed 29649506Tedesco TK, Calvo AF, Lenzi TL, Hesse D, Guglielmi CA, Camargo LB, Gimenez T, Braga MM, Raggio DP. ART is an alternative for restoring occlusoproximal cavities in primary teeth - evidence from an updated systematic review and meta-analysis. Int J Paediatr Dent. 2017 May;27(3):201-209. doi: 10.1111/ipd.12252. Epub 2016 Aug 4.
PubMed 27489205Pitts NB, Richards D. Personalized treatment planning. Monogr Oral Sci. 2009;21:128-143. doi: 10.1159/000224217. Epub 2009 Jun 3.
PubMed 19494680Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.
PubMed 26391116Qvist V, Poulsen A, Teglers PT, Mjor IA. Fluorides leaching from restorative materials and the effect on adjacent teeth. Int Dent J. 2010 Jun;60(3):156-60.
PubMed 20684440Gordan VV, Riley JL 3rd, Rindal DB, Qvist V, Fellows JL, Dilbone DA, Brotman SG, Gilbert GH; National Dental Practice-Based Research Network Collaborative Group. Repair or replacement of restorations: A prospective cohort study by dentists in The National Dental Practice-Based Research Network. J Am Dent Assoc. 2015 Dec;146(12):895-903. doi: 10.1016/j.adaj.2015.05.017.
PubMed 26610834Hickel R, Brushaver K, Ilie N. Repair of restorations--criteria for decision making and clinical recommendations. Dent Mater. 2013 Jan;29(1):28-50. doi: 10.1016/j.dental.2012.07.006. Epub 2012 Aug 3.
PubMed 22867859
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04491981
- Acronym / sponsor ID
- REPAIRC3
- Conditions
- Dental Caries, Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 30 Jul 2020 (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 objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).
Detailed description
Failed restorations in primary teeth will be repaired using GIC or composite resin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encapsulated Glass Ionomer Cement | Experimental | Procedure: Encapsulated Glass Ionomer CementRepair of restorations in primary molars using a high viscosity glass ionomer cement (RIVA Self Cure - SDI) |
| Composite resin | Experimental | Procedure: Composite resinRepair of restorations in primary molars using a composite resin (Filtek Bulk Fill- 3M ESPE) |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who have sought treatment in the School of Dentistry, University of Sao Paulo
- Children between 3 and 10 years old
- Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth
Key exclusion criteria (2 listed)
- Children whose parents did not agree to participate in the study
- Children with behavioural issues at the initial exam or who did not assent to participate in the study
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 |
|---|---|---|
| Encapsulated Glass Ionomer CementRepair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement). | Procedure or surgery | Encapsulated Glass Ionomer Cement |
| Composite resinRepair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin). | Procedure or surgery | Composite resin |
Primary outcome
Clinical success of restorations after repair
Time frame: 24 months
Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations
2 secondary outcomes
Cost- effectiveness of restorations repairs
Time frame: 24 months
Patient's discomfort
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 25048250Opdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, Gaengler P, Lindberg A, Huysmans MC, van Dijken JW. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):943-9. doi: 10.1177/0022034514544217. Epub 2014 Jul 21.
- Background: PubMed 25100406Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.
- Background: PubMed 21719808Gordan VV, Riley JL 3rd, Blaser PK, Mondragon E, Garvan CW, Mjor IA. Alternative treatments to replacement of defective amalgam restorations: results of a seven-year clinical study. J Am Dent Assoc. 2011 Jul;142(7):842-9. doi: 10.14219/jada.archive.2011.0274.
- Background: PubMed 24907560Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.
- Background: PubMed 28602850Casagrande L, Laske M, Bronkhorst EM, Huysmans MCDNJM, Opdam NJM. Repair may increase survival of direct posterior restorations - A practice based study. J Dent. 2017 Sep;64:30-36. doi: 10.1016/j.jdent.2017.06.002. Epub 2017 Jun 8.
- Background: PubMed 28943362Kanzow P, Wiegand A, Gostemeyer G, Schwendicke F. Understanding the management and teaching of dental restoration repair: Systematic review and meta-analysis of surveys. J Dent. 2018 Feb;69:1-21. doi: 10.1016/j.jdent.2017.09.010. Epub 2017 Sep 21.
- Background: PubMed 20059587Qvist V, Poulsen A, Teglers PT, Mjor IA. The longevity of different restorations in primary teeth. Int J Paediatr Dent. 2010 Jan;20(1):1-7. doi: 10.1111/j.1365-263X.2009.01017.x.
- Background: PubMed 29649506Dias AGA, Magno MB, Delbem ACB, Cunha RF, Maia LC, Pessan JP. Clinical performance of glass ionomer cement and composite resin in Class II restorations in primary teeth: A systematic review and meta-analysis. J Dent. 2018 Jun;73:1-13. doi: 10.1016/j.jdent.2018.04.004. Epub 2018 Apr 9.
- Background: PubMed 27489205Tedesco TK, Calvo AF, Lenzi TL, Hesse D, Guglielmi CA, Camargo LB, Gimenez T, Braga MM, Raggio DP. ART is an alternative for restoring occlusoproximal cavities in primary teeth - evidence from an updated systematic review and meta-analysis. Int J Paediatr Dent. 2017 May;27(3):201-209. doi: 10.1111/ipd.12252. Epub 2016 Aug 4.
- Background: PubMed 19494680Pitts NB, Richards D. Personalized treatment planning. Monogr Oral Sci. 2009;21:128-143. doi: 10.1159/000224217. Epub 2009 Jun 3.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Background: PubMed 26391116Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.
- Randomization websiteLink provided by the sponsor.
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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 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 Encapsulated Glass Ionomer Cement and Composite resin in people with Dental Caries and Dental Caries in Children, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2021. 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?
Contact Daniela P Raggio (+5511976922202, danielar@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success of restorations after repair (time frame: 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 NCT04491981, which also lists 17 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 13 Apr 2021.