Selective Dentine Removal in Primary Teeth

NCT03872037 | Completed DMC

• 1 other identifier: SLM 7
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Caries, Dental

Keywords

minimally invasive dentistry; dental caries; dentine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Molars subjected to selective removal and restored with Ketac Molar Easymix

Procedure: Control

Selective removal of caries and restoration with Maxxion

EXPERIMENTAL

Molars subjected to selective removal and restored with Maxxion

Procedure: Selective removal of carious tissue and restoration with Maxxion

Interventions

Selective removal of carious tissue and restoration with Maxxion PROCEDURE

Molars subjected to selective removal and restored with Maxxion

Selective removal of caries and restoration with Maxxion

Control PROCEDURE

Molars subjected to selective removal and restored with Ketac Molar Easymix

Control

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty Sao Leopoldo Mandic Campinas: lead

Study Sites (1)

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

Location

Related Publications (7)

• 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.

  PMID: 27529624 BACKGROUND

• 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.

  PMID: 27705968 BACKGROUND

• 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.

  PMID: 27008258 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24340496 BACKGROUND

• 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.

  PMID: 22103270 BACKGROUND

• 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.

  PMID: 26676191 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Maxxion

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Jose Carlos P Imparato, PhD

  Sao Leopoldo Mandic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer, Clinical Professor

Model Details: 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 Record Dates

• First Submitted: March 4, 2019
• First Posted: March 12, 2019
• Study Start: July 2, 2014
• Primary Completion: February 3, 2016
• Study Completion: February 3, 2017
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

BR (1)