Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-18
First Post:
2024-04-29
Brief Title:
Clinical Efficacy of Calcium and Sodium Phosphosilicate Novamin in the Treatment of MIH Molar Incisor Hypolimineralization in Pediatric Patients
Sponsor:
University of Pavia
Organization:
University of Pavia
Study Overview
Official Title:
Clinical Efficacy of Calcium and Sodium Phosphosilicate Novamin in the Treatment of MIH Molar Incisor Hypolimineralization in Pediatric Patients Randomized Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RepairProtect 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None