Selective Dentine Removal in Primary Teeth

Caries, Dental Clinical Trial

Official title:

Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03872037
• Other study ID #: SLM 7
• Status: Completed
• Phase: N/A
• Start date: July 2, 2014
• Est. completion date: February 3, 2017

Study information

• Verified date: March 2019
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Procedure:
• Selective removal of carious tissue and restoration with Maxxion
Molars subjected to selective removal and restored with Maxxion
• Control
Molars subjected to selective removal and restored with Ketac Molar Easymix

Locations

Country	Name	City	State
Brazil	Faculty Sao Leopoldo Mandic	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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