Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05705037
Other study ID # MIH-2020.1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date May 1, 2023

Study information

Verified date January 2023
Source Università degli Studi di Brescia
Contact Elena Bardellini, AP
Phone +390303995780
Email elena.bardellini@unibs.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 39
Est. completion date May 1, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 14 Years
Eligibility 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.

Study Design


Intervention

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.
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
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.

Locations

Country Name City State
Italy Dental Clinic Brescia

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
See also
  Status Clinical Trial Phase
Completed NCT02753075 - A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice. N/A
Completed NCT06045026 - A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management N/A
Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
Completed NCT02226562 - Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity Phase 2
Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Withdrawn NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT05083052 - Propolis in Reducing Dentin Hypersensitivity N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Not yet recruiting NCT06417580 - Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity Phase 2