Selective Dentine Removal in Primary Teeth

• Sponsor: Faculty Sao Leopoldo Mandic Campinas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03872037
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.1
• Patients Per Site Per Month: 4.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental	Procedure: Selective removal of carious tissue and restoration with Maxxion; Procedure: Control	N/A

Study Design

• Study Type: Interventional
• 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).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: Jul 2, 2014
• Actual Primary Completion Date: Feb 3, 2016
• Actual Study Completion Date: Feb 3, 2017

Arms and Interventions

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

Primary Outcome Measures

1. Number of teeth with treatment-related success as assessed by radiographic analysis. [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. [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

Criteria

• Ages Eligible for Study: 4 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty Sao Leopoldo Mandic	Campinas	Sao Paulo	Brazil	13045755

Sponsors and Collaborators

• Faculty Sao Leopoldo Mandic Campinas

Investigators

• Principal Investigator: Jose Carlos P Imparato, PhD, Sao Leopoldo Mandic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Banerjee A, Doméjean S. The contemporary approach to tooth preservation: minimum intervention (MI) caries management in general practice. Prim Dent J. 2013 Jul;2(3):30-7.
• 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.
• 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. pii: S1806-83242016000100201. doi: 10.1590/1807-3107BOR-2016.vol30.0008. Epub 2015 Dec 15.
• Hannas AR, Kato MT, Cardoso Cde A, Magalhães AC, Pereira JC, Tjäderhane 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.
• 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. Epub 2016 Aug 17.
• Roncalli AG, Sheiham A, Tsakos G, Araújo-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.

• 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: Mar 12, 2019
• Last Update Posted: Mar 14, 2019
• Last Verified: Mar 1, 2019

• 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, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas: minimally invasive dentistry; dental caries; dentine
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Mar 14, 2019