MIH and Hypersensitivity in Children
NCT05705037 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2023-01-30
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 S.r.l.) 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.
Conditions
- Dentin Sensitivity
- Molar Incisor Hypomineralization
Interventions
- OTHER
-
CPP-ACPF
CPP-ACPF mousse (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 S.r.l. 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.
- OTHER
-
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 S.r.l. 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 J/cm2
- OTHER
-
CPP-ACPF+PBMT
CPP-ACPF mousse (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 S.r.l. 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 J/cm2.
Sponsors & Collaborators
-
Università degli Studi di Brescia
lead OTHER
Principal Investigators
-
Elena Bardellini, AP · Università degli Studi di Brescia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-10
- Primary Completion
- 2023-02-10
- Completion
- 2023-05-01
Countries
- Italy
Study Locations
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