IADR Abstract Archives
Efficacy of Self-assembling Peptide P11-4 with Fluoride Varnish or Self-assembling Peptide Matrix for the Treatment of Early Occlusal Carious Lesions
Objectives: To evaluate the efficacy of a combination of Self-Assembling Peptide P11-4 (SAP P11-4) and Fluoride Varnish or SAP P11-4 and Self-Assembling Peptide Matrix Gel (SAPM) in treatment of early occlusal carious lesions compared to the gold-standard Fluoride Varnish (7.700 ppm fluoride).
Methods: 90 subjects with early occlusal carious lesions were included in this radomized,gold standard controlled clinical trial. Test Group 1 received SAP P11-4 and Fluoride Varnish at D0; Test Group 2 received SAP P11-4 on D0 and SAPM was given for 2x per week home-application throughout the 1-year study duration; Control Group received Fluoride Varnish on D0. In addition, Test 1 and Control received Fluoride Varnish on D180. Additional follow-ups were at D90 and D360. Primary parameter was the difference in the change of the Laser Fluorescence between Test 1, Test 2 and Control Group for the time interval D0-D180. Secondary parameters, were differences in the change of Nyvad Caries Activity Criteria, ICDAS-II classification, and VAS progresssion of change.
Results: Self-Assembling Peptide P11-4 applied with Fluoride Varnish or in combination with twice weekly SAPM was superior to Fluoride Varnish alone as assessed by Laser Fluorescence, ICDAS-II classification, Nyvad Caries Activity Criteria and VAS Assessment of Caries Progression. Test Group 1 and 2 performed equally well for treatment of occlusal caries.
Change in the Laser Fluorescence values demonstrated superior results with decreases for Test 1 (-6.7±4.8) and Test 2 (-6.6±6.5) compared to increase for Control lesions (+4.2±6.0) on D180 (p<0.0005). ICDAS-II classification at D360 showed partial regression into smaller ICDAS-II class for Test 1 (6.7%) and Test 2 (20.0%) and partial progression into larger ICDAS II class for Control (23.3%) (p<0.01). Nyvad Caries Activity Criteria yielded superior results for Test 1 and 2 at D360.
Conclusions: Under the conditions of the present clinical trial Self-Assembling Peptide P11-4 applied with Fluoride Varnish or in combination with twice weekly SAPM was superior to Fluoride Varnish alone as assessed by Laser Fluorescence, ICDAS-II classification, Nyvad Caries Activity Criteria and VAS Assessment of Caries Progression. Test Group 1 and 2 performed equally well for treatment of occlusal caries.
Methods: 90 subjects with early occlusal carious lesions were included in this radomized,gold standard controlled clinical trial. Test Group 1 received SAP P11-4 and Fluoride Varnish at D0; Test Group 2 received SAP P11-4 on D0 and SAPM was given for 2x per week home-application throughout the 1-year study duration; Control Group received Fluoride Varnish on D0. In addition, Test 1 and Control received Fluoride Varnish on D180. Additional follow-ups were at D90 and D360. Primary parameter was the difference in the change of the Laser Fluorescence between Test 1, Test 2 and Control Group for the time interval D0-D180. Secondary parameters, were differences in the change of Nyvad Caries Activity Criteria, ICDAS-II classification, and VAS progresssion of change.
Results: Self-Assembling Peptide P11-4 applied with Fluoride Varnish or in combination with twice weekly SAPM was superior to Fluoride Varnish alone as assessed by Laser Fluorescence, ICDAS-II classification, Nyvad Caries Activity Criteria and VAS Assessment of Caries Progression. Test Group 1 and 2 performed equally well for treatment of occlusal caries.
Change in the Laser Fluorescence values demonstrated superior results with decreases for Test 1 (-6.7±4.8) and Test 2 (-6.6±6.5) compared to increase for Control lesions (+4.2±6.0) on D180 (p<0.0005). ICDAS-II classification at D360 showed partial regression into smaller ICDAS-II class for Test 1 (6.7%) and Test 2 (20.0%) and partial progression into larger ICDAS II class for Control (23.3%) (p<0.01). Nyvad Caries Activity Criteria yielded superior results for Test 1 and 2 at D360.
Conclusions: Under the conditions of the present clinical trial Self-Assembling Peptide P11-4 applied with Fluoride Varnish or in combination with twice weekly SAPM was superior to Fluoride Varnish alone as assessed by Laser Fluorescence, ICDAS-II classification, Nyvad Caries Activity Criteria and VAS Assessment of Caries Progression. Test Group 1 and 2 performed equally well for treatment of occlusal caries.