Clinical trial NCT05705037: MIH and Hypersensitivity in Children
Official title: Molar Incisor Hypomineralization and Hypersensitivity in Paediatric Age: a Comparison of Treatment Protocols
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dentin Sensitivity
Molar Incisor Hypomineralization
Keywords: Photobiomodulation
CPP-ACPF
Dentin
Hypersensitivity
Children
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

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 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

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 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

Eligibility criteria: Inclusion Criteria:

* children 6-14 years old
* having at least one MIH-affected tooth and MIH-associated hypersensitivity.

Exclusion Criteria:

* allergy to milk proteins
* chronic diseases,
* carious lesions on the sensitive teeth
* restorations on the sensitive teeth
* other enamel defects (fluorosis, amelogenesis/dentinogenesis imperfecta...)
* presence of orthodontic appliance
* recent anti-inflammatory or cortisone therapies
* recent desensitizing treatments.

Primary outcomes:
measure: Treatment of dental hypersensitivity (DH)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Dental Clinic
Study officials:
affiliation: Università degli Studi di Brescia
name: Elena Bardellini, AP
role: PRINCIPAL_INVESTIGATOR
References: