Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05705037
Status:
RECRUITING
Last Update Posted:
2023-01-30
First Post:
2023-01-21
Brief Title:
MIH and Hypersensitivity in Children
Sponsor:
Università degli Studi di Brescia
Organization:
Università degli Studi di Brescia
Study Overview
Official Title:
Molar Incisor Hypomineralization and Hypersensitivity in Paediatric Age a Comparison of Treatment Protocols
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study was to evaluate the efficacy of the association of casein phosphopeptide plus amorphous calcium phosphate CPP-ACPF mousse and photo-bio-modulation therapy PMBT diode laser RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl in the treatment of dental hypersensitivity DH in children with Molar Incisor Hypomineralization MIH
Children aged 6-14 years with hypersensitive teeth were randomized into 3 groups Group A received the application of CPP-ACPF mousse GC MI Paste and sham light therapy group B got the application of placebo mousse Elmex Junior and PMBT group C received both CPP-ACPF mousse and PMBT
Children aged 6-14 years with hypersensitive teeth were randomized into 3 groups Group A received the application of CPP-ACPF mousse GC MI Paste and sham light therapy group B got the application of placebo mousse Elmex Junior and PMBT group C received both CPP-ACPF mousse and PMBT
Detailed Description:
Three desensitizing treatment sessions for each group group A group B group C were performed with a 7 days-interval The detailed protocol for each treatment is described below
Group A CPP-ACPF mousse sham light therapy CPP-ACPF mousse GC MI Paste was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a sham therapy was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl Although the device was switched on the hand piece did not work and the sound was emitted by a mobile phone The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown
Group B placebo mousse PBMT A placebo mousse Elmex Junior was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a PBMT was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown The parameters used were wavelength 980 nm power 4 W irradiation area1 cm2 application time 15 sec per 1 cm2 energy density 60 Jcm2
Group C CPP-ACPF PBMT CPP-ACPF mousse GC MI Paste was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a PBMT was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown The parameters used were wavelength 980 nm power 4 W irradiation area1 cm2 application time 15 sec per 1 cm2 energy density 60 Jcm2
Group A CPP-ACPF mousse sham light therapy CPP-ACPF mousse GC MI Paste was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a sham therapy was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl Although the device was switched on the hand piece did not work and the sound was emitted by a mobile phone The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown
Group B placebo mousse PBMT A placebo mousse Elmex Junior was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a PBMT was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown The parameters used were wavelength 980 nm power 4 W irradiation area1 cm2 application time 15 sec per 1 cm2 energy density 60 Jcm2
Group C CPP-ACPF PBMT CPP-ACPF mousse GC MI Paste was applied with a microbrush on the cervical buccal surface of each tooth for 5 minutes and it was subsequently distributed for 20 seconds with a rubber cup coupled to a low speed handpiece Right after a PBMT was performed using RAFFAELLO 980 BIO - Dental Medical Technologies - DMT Srl The tip of the laser device was positioned on two areas for each dental element located one in the center of the cervical region and the other in the middle third of the crown The parameters used were wavelength 980 nm power 4 W irradiation area1 cm2 application time 15 sec per 1 cm2 energy density 60 Jcm2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None