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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Bleeding Index — Study begin, 1, 3, 6, 9, 12 months
  0: absence of bleeding after 30 seconds 1. bleeding observed after 30 seconds 2. immediate bleeding
• Change in Gingival Index — Study begin, 1, 3, 6, 9, 12 months
  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
• Change in Plaque Control Record — Study begin, 1, 3, 6, 9, 12 months
  The index is calculated multiplying the total number of surfaces with plaque per 100
• Change in Schiff Air Index — Study begin, 1, 3, 6, 9, 12 months
  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
• Change in Basic Erosive Wear Examination — Study begin, 1, 3, 6, 9, 12 months
  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
• Change in Wong- Backer faces pain rating scales — 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

Trial sites (1)

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