Selective Dentine Removal in Primary Teeth
Primary Purpose
Caries, Dental
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Selective removal of carious tissue and restoration with Maxxion
Control
Sponsored by
About this trial
This is an interventional treatment trial for Caries, Dental focused on measuring minimally invasive dentistry, dental caries, dentine
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Faculty Sao Leopoldo Mandic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Selective removal of caries and restoration with Maxxion
Arm Description
Molars subjected to selective removal and restored with Ketac Molar Easymix
Molars subjected to selective removal and restored with Maxxion
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03872037
First Posted
March 4, 2019
Last Updated
March 12, 2019
Sponsor
Faculty Sao Leopoldo Mandic Campinas
1. Study Identification
Unique Protocol Identification Number
NCT03872037
Brief Title
Selective Dentine Removal in Primary Teeth
Official Title
Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2, 2014 (Actual)
Primary Completion Date
February 3, 2016 (Actual)
Study Completion Date
February 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty Sao Leopoldo Mandic Campinas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
minimally invasive dentistry, dental caries, dentine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
For the radiographic evaluation, the evaluators had no information about the group to which the parent was randomized. Only the periapical tissues were evaluated, and the coronary portion of the restored tooth was concealed with adhesive tape.
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Molars subjected to selective removal and restored with Ketac Molar Easymix
Arm Title
Selective removal of caries and restoration with Maxxion
Arm Type
Experimental
Arm Description
Molars subjected to selective removal and restored with Maxxion
Intervention Type
Procedure
Intervention Name(s)
Selective removal of carious tissue and restoration with Maxxion
Intervention Description
Molars subjected to selective removal and restored with Maxxion
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Molars subjected to selective removal and restored with Ketac Molar Easymix
Primary Outcome Measure Information:
Title
Number of teeth with treatment-related success as assessed by radiographic analysis.
Description
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Time Frame
14-month
Title
Number of teeth with treatment-related success as assessed by radiographic analysis.
Description
To evaluate the longevity of primary molar teeth with an occluso-proximal cavity that was treated with the selective removal of carious tissue.
Time Frame
24-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carlos P Imparato, PhD
Organizational Affiliation
Sao Leopoldo Mandic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty Sao Leopoldo Mandic
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13045755
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27529624
Citation
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.
Results Reference
background
PubMed Identifier
27705968
Citation
Roncalli 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.
Results Reference
background
PubMed Identifier
27008258
Citation
Hannas 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.
Results Reference
background
Citation
Bjørndal 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.
Results Reference
background
PubMed Identifier
24340496
Citation
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.
Results Reference
background
PubMed Identifier
22103270
Citation
Baelum 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.
Results Reference
background
PubMed Identifier
26676191
Citation
Calvo 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.
Results Reference
background
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Selective Dentine Removal in Primary Teeth
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