Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538142
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Photobiomodulation and New Restorative Material for Teeth With MIH on Control of Hypersensitivity and Longevity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Photobiomodulation Combined With New Restorative Material for Teeth With Molar Incisor Hypomineralization on Control of Hypersensitivity and Longevity of Restorations Randomized Controlled Blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Molar incisor hypomineralization MIH is a qualitative defect of enamel development that occurs in the mineralization phase MIH affects one or more permanent molars and occasionally permanent incisors
Objective The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries The clinical performance of the self-cure composite resin will also be assessed through an analysis of restoration longevity
Methods and analysis Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups Group 1 photobiomodulation self-cure composite resin restoration Group 2 self-cure composite resin restoration Group 3 photobiomodulation restoration in bulk-fill photopolymerizable composite resin Photobiomodulation will be performed in a single session involving low-level laser administered to four different points The laser will be used at a wavelength of 808 nm power of 100 mW and energy of 1 J per points irradiance will be 3571 mWcm² with a total radiant exposure of 357 Jcm² The data will be analyzed using descriptive statistics Associations with age and sex will be tested using either the chi-square test or Fishers exact test Pearsons correlation coefficients will be calculated to determine the strength of correlations between variables Kaplan-Meier survival analysis will be performed to assess the performance of the restorations
Objective The aim of the proposed study is to determine whether photobiomodulation combined with a new self-cure resin improves hypersensitivity in molars with MIH and caries The clinical performance of the self-cure composite resin will also be assessed through an analysis of restoration longevity
Methods and analysis Permanent molars with MIH in patients eight to 12 years of age will be allocated to three groups Group 1 photobiomodulation self-cure composite resin restoration Group 2 self-cure composite resin restoration Group 3 photobiomodulation restoration in bulk-fill photopolymerizable composite resin Photobiomodulation will be performed in a single session involving low-level laser administered to four different points The laser will be used at a wavelength of 808 nm power of 100 mW and energy of 1 J per points irradiance will be 3571 mWcm² with a total radiant exposure of 357 Jcm² The data will be analyzed using descriptive statistics Associations with age and sex will be tested using either the chi-square test or Fishers exact test Pearsons correlation coefficients will be calculated to determine the strength of correlations between variables Kaplan-Meier survival analysis will be performed to assess the performance of the restorations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None