Selective Dentine Removal in Primary Teeth

Study Overview
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Brief Summary
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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).

Official Title
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Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial

Conditions
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Caries, Dental

Intervention / Treatment
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* Procedure: Selective removal of carious tissue and restoration with Maxxion
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Molars subjected to selective removal and restored with Ketac Molar Easymix | Procedure: Control<br>* Molars subjected to selective removal and restored with Ketac Molar Easymix<br>|
| Experimental: Selective removal of caries and restoration with Maxxion<br>Molars subjected to selective removal and restored with Maxxion | Procedure: Selective removal of carious tissue and restoration with Maxxion<br>* Molars subjected to selective removal and restored with Maxxion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive dentistry, dental caries, dentine