Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novamin application, Parodontax application.
- Who it may be relevant to
- Registry conditions: Molar Incisor Hypomineralization. Basic parameters: 7 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Efficacy of Calcium and Sodium Phosphosilicate (Novamin) in the Treatment of MIH (Molar Incisor Hypolimineralization) in Pediatric Patients: Randomized Clinical Trial
Overview
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
- 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). - 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).
Primary outcome measures
- Change in Bleeding Index [Time frame: Study begin, 1, 3, 6, 9, 12 months]
- Change in Gingival Index [Time frame: Study begin, 1, 3, 6, 9, 12 months]
- Change in Plaque Control Record [Time frame: Study begin, 1, 3, 6, 9, 12 months]
- Change in Schiff Air Index [Time frame: Study begin, 1, 3, 6, 9, 12 months]
- Change in Basic Erosive Wear Examination [Time frame: Study begin, 1, 3, 6, 9, 12 months]
- Change in Wong- Backer faces pain rating scales [Time frame: Study begin, 1, 3, 6, 9, 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT06396988 · 2024-MIHNOVAMIN