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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Other: Novamin application; Other: Parodontax application

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novamin	Other: 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).
Active Comparator: Parodontax	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bleeding Index	0: absence of bleeding after 30 seconds; bleeding observed after 30 seconds; immediate bleeding	Study begin, 1, 3, 6, 9, 12 months
Change in Gingival Index	0: normal gingiva; mild inflammation, edema and swelling, no bleeding; moderate inflammation with edema, sweelling and bleeding on probing; severe inflammation with marked edema, redness tissues, ulceration and spontaneous bleeding	Study begin, 1, 3, 6, 9, 12 months
Change in Plaque Control Record	The index is calculated multiplying the total number of surfaces with plaque per 100	Study begin, 1, 3, 6, 9, 12 months
Change in Schiff Air Index	0: the subject did not respond to air blasting; the subject responded to air blasting; the subject responded to air blasting and requested discontinuation; the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful	Study begin, 1, 3, 6, 9, 12 months
Change in Basic Erosive Wear Examination	0: no erosive tooth wear; initial loss of surface texture; distinct defect, hard tissue loss < 50% of the surface area; hard tissue loss ≥ 50% of the surface area	Study begin, 1, 3, 6, 9, 12 months
Change in Wong- Backer faces pain rating scales	0-1: no pain 1-2: milde pain 3-4: moderate pain 5-6: acute pain 7-8: very severe pain 9-10: unbearable pain	Study begin, 1, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Molar Hypomineralization
• Other Study ID Numbers: 2024-MIHNOVAMIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No