Caries, DentalNCT03872037
Selective Dentine Removal in Primary Teeth
A study testing Selective removal of carious tissue and restoration with Maxxion in people with Caries, Dental, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- Selective removal of carious tissue and restoration with Maxxion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2014to 3 Feb 2017
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- An active denture caries lesion
- The molars in primary, without anterior restoration, with the exclusive involvement of occlusal and mesial or distal surfaces present (International Caries Detection and Evaluation System, ICDAS score 5)
Who cannot join
- Those who did not accept care after 3 adaptation sessions
- Teeth with the following characteristics were excluded from the study: spontaneous pain, pressure sensitivity, suspected cellulose involvement, necrosis pulp, fistula, or tooth mobility
- Teeth in which extension of the lesion could lead to pulpal exposure were excluded
- Children whose parents or guardians do not sign an Informed Consent Term
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial
Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment.
Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
- Conditions
- Caries, Dental
- Being tested
- Selective removal of carious tissue and restoration with Maxxion, Control
- Keywords
- minimally invasive dentistry, dental caries, dentine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective removal of carious tissue and restoration with MaxxionProcedure or surgery
Molars subjected to selective removal and restored with Maxxion
ControlProcedure or surgery
Molars subjected to selective removal and restored with Ketac Molar Easymix
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Molars subjected to selective removal and restored with Ketac Molar Easymix Receives: Procedure: Control |
| Selective removal of caries and restoration with Maxxion | Experimental | Molars subjected to selective removal and restored with Maxxion Receives: Procedure: Selective removal of carious tissue and restoration with Maxxion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth with treatment-related success as assessed by radiographic analysis.
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Measured: 14-month
Number of teeth with treatment-related success as assessed by radiographic analysis.
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start2 Jul 2014
- Primary completion3 Feb 2016
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
- Investigators
- Jose Carlos P Imparato, PhD, Principal investigator, Sao Leopoldo Mandic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872037
- Sponsor's protocol ID
- SLM 7
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Priesnitz MC, Celeste RK, Pereira MJ, Pires CA, Feldens CA, Kramer PF. Neighbourhood Determinants of Caries Experience in Preschool Children: A Multilevel Study. Caries Res. 2016;50(5):455-461. doi: 10.1159/000447307. Epub 2016 Aug 17.
PubMed 27529624Roncalli AG, Sheiham A, Tsakos G, Araujo-Souza GC, Watt RG. Social Factors Associated with the Decline in Caries in Brazilian Children between 1996 and 2010. Caries Res. 2016;50(6):551-559. doi: 10.1159/000442899. Epub 2016 Oct 6.
PubMed 27705968Hannas AR, Kato MT, Cardoso Cde A, Magalhaes AC, Pereira JC, Tjaderhane L, Buzalaf MA. Preventive effect of toothpastes with MMP inhibitors on human dentine erosion and abrasion in vitro. J Appl Oral Sci. 2016 Jan-Feb;24(1):61-6. doi: 10.1590/1678-775720150289.
PubMed 27008258Bjørndal L, Ricucci D, 2014. Pulp inflammation: from the reversible inflammation to pulp necrosis during caries progression. In Michel G ed. The Dental Pulp Biology, Pathology, and Regenerative Therapies. Berlin (Germany): Springer. pp 125-139.
Banerjee A, Domejean S. The contemporary approach to tooth preservation: minimum intervention (MI) caries management in general practice. Prim Dent J. 2013 Jul;2(3):30-7. doi: 10.1308/205016813807440119.
PubMed 24340496Baelum V, Hintze H, Wenzel A, Danielsen B, Nyvad B. Implications of caries diagnostic strategies for clinical management decisions. Community Dent Oral Epidemiol. 2012 Jun;40(3):257-66. doi: 10.1111/j.1600-0528.2011.00655.x. Epub 2011 Nov 21.
PubMed 22103270Calvo AF, Kicuti A, Tedesco TK, Braga MM, Raggio DP. Evaluation of the relationship between the cost and properties of glass ionomer cements indicated for atraumatic restorative treatment. Braz Oral Res. 2016;30:S1806-83242016000100201. doi: 10.1590/1807-3107BOR-2016.vol30.0008. Epub 2015 Dec 15.
PubMed 26676191
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03872037
- Acronym / sponsor ID
- SLM 7
- Conditions
- Caries, Dental
- Keywords
- minimally invasive dentistry, dental caries, dentine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 2 Jul 2014 (actual)
- Primary completion
- 3 Feb 2016 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 12 Mar 2019 (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.
Background There is little information regarding the longevity of the restored tooth, considering the health of the pulp-dentine complex, in children who do not sufficiently cooperate with dental treatment.
Aim To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Design A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 150 children were allocated to two parallel groups: group 1 (G1, n = 70, control, Ketac Molar Easymix®, 3M/ESPE, Seefeld, GE) and group 2 (G2, n = 80, test, Maxxion®, FGM, Joinville, BR). The study was double-blinded, and an operator specialized in paediatric dentistry performed the selective removal of soft dentine and the restoration of the cavity with GIC. During the follow-up periods, the teeth were evaluated via periapical radiography by two trained examiners specialized in radiology. Statistical analysis was performed using Stata 11.2 software (StataCorp, Texas, USA) and a survival curve (Kaplan-Meier).
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: ControlMolars subjected to selective removal and restored with Ketac Molar Easymix |
| Selective removal of caries and restoration with Maxxion | Experimental | Procedure: Selective removal of carious tissue and restoration with MaxxionMolars subjected to selective removal and restored with Maxxion |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- An active denture caries lesion
- The molars in primary, without anterior restoration, with the exclusive involvement of occlusal and mesial or distal surfaces present (International Caries Detection and Evaluation System, ICDAS score 5)
Key exclusion criteria (4 listed)
- Those who did not accept care after 3 adaptation sessions
- Teeth with the following characteristics were excluded from the study: spontaneous pain, pressure sensitivity, suspected cellulose involvement, necrosis pulp, fistula, or tooth mobility
- Teeth in which extension of the lesion could lead to pulpal exposure were excluded
- Children whose parents or guardians do not sign an Informed Consent Term
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 |
|---|---|---|
| Selective removal of carious tissue and restoration with MaxxionMolars subjected to selective removal and restored with Maxxion | Procedure or surgery | Selective removal of caries and restoration with Maxxion |
| ControlMolars subjected to selective removal and restored with Ketac Molar Easymix | Procedure or surgery | Control |
Primary outcome
Number of teeth with treatment-related success as assessed by radiographic analysis.
Time frame: 14-month
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Number of teeth with treatment-related success as assessed by radiographic analysis.
Time frame: 24-month
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
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 14 Mar 2019.
- Background: PubMed 27529624Priesnitz MC, Celeste RK, Pereira MJ, Pires CA, Feldens CA, Kramer PF. Neighbourhood Determinants of Caries Experience in Preschool Children: A Multilevel Study. Caries Res. 2016;50(5):455-461. doi: 10.1159/000447307. Epub 2016 Aug 17.
- Background: PubMed 27705968Roncalli AG, Sheiham A, Tsakos G, Araujo-Souza GC, Watt RG. Social Factors Associated with the Decline in Caries in Brazilian Children between 1996 and 2010. Caries Res. 2016;50(6):551-559. doi: 10.1159/000442899. Epub 2016 Oct 6.
- Background: PubMed 27008258Hannas AR, Kato MT, Cardoso Cde A, Magalhaes AC, Pereira JC, Tjaderhane L, Buzalaf MA. Preventive effect of toothpastes with MMP inhibitors on human dentine erosion and abrasion in vitro. J Appl Oral Sci. 2016 Jan-Feb;24(1):61-6. doi: 10.1590/1678-775720150289.
- BackgroundBjørndal L, Ricucci D, 2014. Pulp inflammation: from the reversible inflammation to pulp necrosis during caries progression. In Michel G ed. The Dental Pulp Biology, Pathology, and Regenerative Therapies. Berlin (Germany): Springer. pp 125-139.
- Background: PubMed 24340496Banerjee A, Domejean S. The contemporary approach to tooth preservation: minimum intervention (MI) caries management in general practice. Prim Dent J. 2013 Jul;2(3):30-7. doi: 10.1308/205016813807440119.
- Background: PubMed 22103270Baelum V, Hintze H, Wenzel A, Danielsen B, Nyvad B. Implications of caries diagnostic strategies for clinical management decisions. Community Dent Oral Epidemiol. 2012 Jun;40(3):257-66. doi: 10.1111/j.1600-0528.2011.00655.x. Epub 2011 Nov 21.
- Background: PubMed 26676191Calvo AF, Kicuti A, Tedesco TK, Braga MM, Raggio DP. Evaluation of the relationship between the cost and properties of glass ionomer cements indicated for atraumatic restorative treatment. Braz Oral Res. 2016;30:S1806-83242016000100201. doi: 10.1590/1807-3107BOR-2016.vol30.0008. Epub 2015 Dec 15.
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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.
Jose Carlos P Imparato, PhD principal investigator
Sao Leopoldo Mandic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective removal of carious tissue and restoration with Maxxion in people with Caries, Dental, run by Faculty Sao Leopoldo Mandic Campinas 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 2 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 14 Mar 2019. 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?
Number of teeth with treatment-related success as assessed by radiographic analysis. (time frame: 14-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03872037, which also lists 7 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 14 Mar 2019.