Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2027-01-15

Brief Summary

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The aim of the following study is to evaluate the clinical efficacy of a toothpaste with calcium and sodium phosphosilicate in the treatment of demineralization of the dental enamel of molars and incisors in pediatric patients. Patients who agree to participate to the study will use 2 different toothpaste Sensodyne Repair and Protect and Parodontax, which will used with split mouth design. The following indices will be measured: BEWE, Bleeding Index, Gingival Index, Plaque Index, Dental sensitivity test- Schiff, Pain Intensity Index- VAS and PPD.

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Detailed Description

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Informed consent will be signed by the parents of the patients underage and will be asked the approval for the attendance of the study. To the parents of pediatric patients will be given for free the 2 toothpastes and will be explain the correct procedures for home oral care. The method used in the study is "Split-Mouth" design, in which contralateral teeth with MIH will used for control group. For the study the patients must have at least two demineralizations present on contralateral permanent molars or incisors. The toothpaste used for the study consist in 2 different types: Sensodyne Repair\&Protect (used for the Trial group) and Parodontax Complete Protection (used for the control group).

The 2 toothpastes will be applied once a day, before going to sleep after normal oral hygiene, for at least two minutes for 28 days after each meeting. The products must be used in minimal quantities, in pea-size doses, applying it on the tooth with the finger while performing a massage, under the supervision of the parents and then rinsing.

At each meeting will be taken all the indices and the timing is: T0- study begin, T1- after 1 month, T2-after 3 months, T3- after 6 months, T4- after 9 months, T5- after 12 months.

Conditions

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Molar Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-mouth study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Novamin

Group Type EXPERIMENTAL

Novamin application

Intervention Type OTHER

Teeth from this group will be treated with the application of Sensodyne Repair\&Protect Toothpaste for 28 days after each visit (1 application per day for 2 minutes).

Parodontax

Group Type ACTIVE_COMPARATOR

Parodontax application

Intervention Type OTHER

Teeth from this group will be treated with the application of Parodontax Complete Protection Toothpaste for 28 days after each visit (1 application per day for 2 minutes).

Interventions

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Novamin application

Teeth from this group will be treated with the application of Sensodyne Repair\&Protect Toothpaste for 28 days after each visit (1 application per day for 2 minutes).

Intervention Type OTHER

Parodontax application

Teeth from this group will be treated with the application of Parodontax Complete Protection Toothpaste for 28 days after each visit (1 application per day for 2 minutes).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presence of at least 2 demineralizations of the dental enamel of molars and incisors (molar incisor hypomineralization-MIH) on contralateral permanent teeth
* Patients with mild or moderate MIH
* Good general health (absence of particular systemic pathologies)

Exclusion Criteria

* Patients undergoing orthodontic therapy
* Patients taking drugs
* Patients with severe MIH (tooth surface with defect \> 2/3, post-eruptive enamel breakage)

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No