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Completed NCT05676671

Microbiological Evaluation and Clinical 24-month Follow-up of Adhesive Systems on Carious Dentin

Conditions: Dental Caries

Sex: All
Ages: 6 Years – 9 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 104
Sponsor: University of Sao Paulo

Location: Brazil

Summary

The objectives were to evaluate the antibacterial effect of self-etching adhesives on carious dentin and the clinical results of restorations in a randomized controlled clinical trial. 104 carious deciduous molars (n=92) were randomly allocated to receive one of the self-etching adhesives: Clearfil SE Bond - control (CB - n =53) or Clearfil SE Protect containing MDPB (CP - n=51) after caries removal selective. Clinical, radiographic, photographic and plaster model assessments (n=53 deciduous molars, CB=29, CP=24) of resin restorations were performed at baseline and at 6, 12, and 24 months. Dentin samples (n=51 deciduous teeth; CB=24 and CP=27) were collected immediately after excavation of carious dentin and 3 months later, and cultured for mutans streptococci - (MS), lactobacilli (LB) and total microorganisms (TM). Data were statistically analyzed (p<0.05).

Eligibility Criteria

Inclusion Criteria:deciduous molars with one or two surfaces with caries lesions;children without systemic problems and who were not using any medication;absence of spontaneous pain, edema or fistula, and dental mobility;radiographically, caries lesions in the inner half of the dentin thickness, absence of pulp contact with the lesion, absence of internal or external root resorption, and other changes suggestive of degenerative pulp conditions, such as radiolucencies in the furcation or periapical regions or widening of periodontal spaces.Exclusion Criteria:Caries lesions with involvement of the pulp or periodontal tissues;Children with systemic problems.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05676671). StuddyBuddy aggregates publicly available trial information.