NCT03872037

Selective Dentine Removal in Primary Teeth

Selective Dentine Removal in Primary Teeth: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Faculty Sao Leopoldo Mandic Campinas · Academic / Other
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	Selective removal of carious tissue and restoration with Maxxion	Molars subjected to selective removal and restored with Maxxion
PROCEDURE	Control	Molars subjected to selective removal and restored with Ketac Molar Easymix

Timeline

• Start date: 2014-07-02
• Primary completion: 2016-02-03
• Completion: 2017-02-03
• First posted: 2019-03-12
• Last updated: 2019-03-14

Locations

1 site across 1 country: Brazil