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

NCT06396988 | Enrolling By Invitation

• 1 other identifier: 2024-MIHNOVAMIN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (6)

• Change in Bleeding Index

  0: absence of bleeding after 30 seconds 1. bleeding observed after 30 seconds 2. immediate bleeding

  Study begin, 1, 3, 6, 9, 12 months

• Change in Gingival Index

  0: normal gingiva 1. mild inflammation, edema and swelling, no bleeding 2. moderate inflammation with edema, sweelling and bleeding on probing 3. 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 1. the subject responded to air blasting 2. the subject responded to air blasting and requested discontinuation 3. 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 1. initial loss of surface texture 2. distinct defect, hard tissue loss \< 50% of the surface area 3. 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

Study Arms (2)

Novamin

EXPERIMENTAL

Other: Novamin application

Parodontax

ACTIVE COMPARATOR

Other: Parodontax application

Interventions

Novamin application 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).

Novamin

Parodontax application 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).

Parodontax

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Split-mouth study

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)