search
Back to results

MIH and Hypersensitivity in Children

Primary Purpose

Dentin Sensitivity, Molar Incisor Hypomineralization

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CPP-ACPF
PBMT
CPP-ACPF+PBMT
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity focused on measuring Photobiomodulation, CPP-ACPF, Dentin, Hypersensitivity, Children

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dental ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Placebo Comparator

Experimental

Arm Label

Group A (CPP-ACPF mousse + sham light therapy)

Group B (placebo mousse + PBMT)

Group C (CPP-ACPF + PBMT)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Treatment of dental hypersensitivity (DH)
The efficacy of the treatment of dental hypersensitivity was evaluated using the Visual Analogue Scale (VAS), ranging from 0 to 10, with 0=no pain and 10= worst possible pain. The evaluation was performed at the following time points: before (T0) and after (T1) the first session, after the second session (T2) on the 7th day, after the third session (T3) on the 14th day and after 4 weeks from the starting (T4) on the 28th day.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
January 21, 2023
Sponsor
Università degli Studi di Brescia
search

1. Study Identification

Unique Protocol Identification Number
NCT05705037
Brief Title
MIH and Hypersensitivity in Children
Official Title
Molar Incisor Hypomineralization and Hypersensitivity in Paediatric Age: a Comparison of Treatment Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity, Molar Incisor Hypomineralization
Keywords
Photobiomodulation, CPP-ACPF, Dentin, Hypersensitivity, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (CPP-ACPF mousse + sham light therapy)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Group B (placebo mousse + PBMT)
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Group C (CPP-ACPF + PBMT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
CPP-ACPF
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PBMT
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
CPP-ACPF+PBMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment of dental hypersensitivity (DH)
Description
The efficacy of the treatment of dental hypersensitivity was evaluated using the Visual Analogue Scale (VAS), ranging from 0 to 10, with 0=no pain and 10= worst possible pain. The evaluation was performed at the following time points: before (T0) and after (T1) the first session, after the second session (T2) on the 7th day, after the third session (T3) on the 14th day and after 4 weeks from the starting (T4) on the 28th day.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Bardellini, AP
Phone
+390303995780
Email
elena.bardellini@unibs.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Bardellini, AP
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Clinic
City
Brescia
ZIP/Postal Code
25133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Bardellini, AP
Phone
+390303995780
Email
elena.bardellini@unibs.it

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MIH and Hypersensitivity in Children

We'll reach out to this number within 24 hrs