Clinical trial NCT06396988: Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients
Official title: Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 \&gt; 2/3, post-eruptive enamel breakage)

Primary outcomes:
measure: Change in Bleeding Index
timeFrame: Study begin, 1, 3, 6, 9, 12 months
measure: Change in Gingival Index
timeFrame: Study begin, 1, 3, 6, 9, 12 months
measure: Change in Plaque Control Record
timeFrame: Study begin, 1, 3, 6, 9, 12 months
measure: Change in Schiff Air Index
timeFrame: Study begin, 1, 3, 6, 9, 12 months
measure: Change in Basic Erosive Wear Examination
timeFrame: Study begin, 1, 3, 6, 9, 12 months
measure: Change in Wong- Backer faces pain rating scales
timeFrame: Study begin, 1, 3, 6, 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: