NCT04195022

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth

Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Faculty Sao Leopoldo Mandic Campinas · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Accepted

Summary

Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
PROCEDURE	Dental Restoration with Chemically activated Composite resin Alkasite	Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
PROCEDURE	Dental Restoration with Bulk fill resin composite	Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2019-12-11
• Last updated: 2019-12-11

Locations

1 site across 1 country: Brazil