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

Molar Incisor Hypomineralization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06396988
• Other study ID #: 2024-MIHNOVAMIN
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: January 15, 2027

Study information

• Verified date: June 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: January 15, 2027
• Est. primary completion date: January 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Molar Incisor Hypomineralization

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bleeding Index	0: absence of bleeding after 30 seconds; bleeding observed after 30 seconds; immediate bleeding	Study begin, 1, 3, 6, 9, 12 months
Primary	Change in Gingival Index	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	Study begin, 1, 3, 6, 9, 12 months
Primary	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
Primary	Change in Schiff Air Index	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	Study begin, 1, 3, 6, 9, 12 months
Primary	Change in Basic Erosive Wear Examination	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	Study begin, 1, 3, 6, 9, 12 months
Primary	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