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Selective Dentine Removal in Primary Teeth

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ClinicalTrials.gov Identifier: NCT03872037
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

Study Description
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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).


Condition or disease Intervention/treatment Phase
Caries, Dental Procedure: Selective removal of carious tissue and restoration with Maxxion Procedure: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial
Actual Study Start Date : July 2, 2014
Actual Primary Completion Date : February 3, 2016
Actual Study Completion Date : February 3, 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
Molars subjected to selective removal and restored with Ketac Molar Easymix
 Procedure: Control
Molars subjected to selective removal and restored with Ketac Molar Easymix
Experimental: Selective removal of caries and restoration with Maxxion
Molars subjected to selective removal and restored with Maxxion
 Procedure: Selective removal of carious tissue and restoration with Maxxion
Molars subjected to selective removal and restored with Maxxion


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872037


Locations
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Brazil
Faculty Sao Leopoldo Mandic
Campinas, Sao Paulo, Brazil, 13045755
Sponsors and Collaborators
Faculty Sao Leopoldo Mandic Campinas
Investigators
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Principal Investigator: Jose Carlos P Imparato, PhD Sao Leopoldo Mandic
More Information
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Publications:
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.

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Responsible Party: Jose Carlos P Imparato, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas
ClinicalTrials.gov Identifier: NCT03872037    
Other Study ID Numbers: SLM 7
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas:
minimally invasive dentistry
dental caries
dentine
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases