Molar Incisor Hypomineralization
Conditions
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.
Interventions
OTHERNovamin 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).
OTHERParodontax 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).
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-mouth study
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed