Clinical trial NCT03872037: Selective Dentine Removal in Primary Teeth
Official title: Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries, Dental
Keywords: minimally invasive dentistry
dental caries
dentine
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of teeth with treatment-related success as assessed by radiographic analysis.
timeFrame: 14-month
measure: Number of teeth with treatment-related success as assessed by radiographic analysis.
timeFrame: 24-month
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculty Sao Leopoldo Mandic
state: Sao Paulo
Study officials:
affiliation: Sao Leopoldo Mandic
name: Jose Carlos P Imparato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.