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NCT Number: NCT06396988

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

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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Key information

Conditions

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

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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).

Primary outcomes

  1. Change in Bleeding Index

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    0: absence of bleeding after 30 seconds

    • bleeding observed after 30 seconds
    • immediate bleeding

  2. Change in Gingival Index

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    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

  3. Change in Plaque Control Record

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    The index is calculated multiplying the total number of surfaces with plaque per 100

  4. Change in Schiff Air Index

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    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

  5. Change in Basic Erosive Wear Examination

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    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

  6. Change in Wong- Backer faces pain rating scales

    Time frame: Study begin, 1, 3, 6, 9, 12 months

    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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 2, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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