Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426108
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-12
Brief Title:
Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Association of Low-intensity Laser and a Remineralizing Agent in Controlling the Pain of Incisor Molar Hypomineralization in Children a Randomized Placebo-controlled Triple-blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
LBIARHMI
Brief Summary:
Molar incisor hypomineralization MIH manifests as a qualitative demarcated defect in tooth enamel of systemic origin predominantly affecting one or more permanent first molars and potentially extending to the incisors One significant challenge in managing this enamel anomaly is hypersensitivity leading to discomfort and pain in affected patients Low-intensity laser therapy alone or combined with other modalities appears promising in alleviating pain associated with MIH This study aims to assess the efficacy of low-intensity laser therapy using varied parameters in conjunction with a remineralizing agent for pain management in children with molar incisor hypomineralization Participants aged 6 to 12 years will be recruited with a total of 88 teeth diagnosed with MIH presenting a sensitivity score 3 on the Visual Analog Scale VAS and a score 1 on the Schiff Cold Air Sensitivity Scale SCASS The teeth will be randomly assigned to one of four groups n22 each Group I GI L-1J VF Group II GII L-1J VP Group III GIII L-2J VF and Group IV GIV L-2J VP Here L denotes low-intensity laser application at different parameters 1J and 2J combined with either fluoride varnish VF or a placebo varnish VP Interventions and assessments will be conducted initially after 48 hours and at 1 and 2 weeks post-treatment Patients will undergo re-evaluation at 2 4 8 and 12 weeks following interventions Statistical analyses will be performed with a 95 confidence level α 005
Detailed Description:
A randomized clinical trial will be carried out involving children aged 6 to 12 years with a total of 88 teeth diagnosed with MIH presenting a sensitivity score 3 on the visual analogue scale VAS and a score 1 on the Schiff Cold Air Sensitivity Scale SCASS Inclusion criteria will require the presence of at least one erupted permanent molar with an occlusal surface free of gingival tissue demonstrating IMH with sensitivity Additionally participants must provide informed consent forms signed by parents or guardians along with consent forms signed by children Exclusion criteria include decayed teeth atypical carious lesions teeth that have other enamel defects such as fluorosis enamel hypoplasia amelogenesis imperfecta or enamel malformations associated with syndromes ongoing orthodontic treatment cognitive disorders in patients desensitizing treatments recent use in the last 3 months previous use of anti-inflammatory andor analgesic medications teeth diagnosed with MIH presenting post-eruptive dentin fractures atypical restorations atypical caries sensitivity scores 3 on the visual analogue scale VAS and scores 1 on the Schiff Cold Air Sensitivity Scale SCASS
For the diagnosis of MIH the investigators will employ the criteria outlined by the European Academy of Pediatric Dentistry which includes assessment of demarcated opacities post-eruptive enamel defects atypical restorations teeth lost due to MIH and incompletely erupted teeth The sample size was determined based on the anticipated outcome of pain reduction following treatment with an expected 60 reduction Calculation was conducted with a confidence level of 95 and a power of 80
Following the application of the inclusion and exclusion criteria each group will consist of a total of 88 teeth randomly assigned to one of four groups GI GII GIII and GIV The interventions for each group will be as follows
GI Low-Intensity Laser 1J 10 seconds Fluoride Varnish GII Low-Intensity Laser 1J 10 seconds Placebo GIII Low-Intensity Laser 2J 20 seconds Fluoride Varnish GIV Low-Intensity Laser 2J 20 seconds Placebo
To administer laser therapy the investigators will utilize a low-intensity infrared diode laser Therapy EC DMC Equipamentos Ltda São Carlos Brazil operating in continuous mode emitting at a wavelength of 808 nm with a power output of 100 mW The dosage will be set at either 1 or 2 Joules with a fluence of 35 Jcm2 Both the operator and the patient will wear personal protective equipment PPE during the procedure The tooth will be irradiated perpendicular to the tooth surface targeting the cervical third of the buccal surface both mesial and distal aspects as well as the center of the lesion Activation time will be either 10 or 20 seconds corresponding to 1 or 2 Joules respectively depending on the assigned group To ensure consistency even if the laser is activated for 1 Joule equivalent to 10 seconds the laser tip will be maintained in place for a standardized duration of 20 seconds the maximum activation time as confirmed by a stopwatch in all applications to ensure reliability
As an adjunct to LBI the investigators will use a fluoride varnish FV and a placebo varnish PV without the active ingredient ensuring that they are in identical packaging with the same taste and texture Both will maintain the same method of application The FV used will be Duraphat 22600 ppm F Colgate The application of both FV and PV will be conducted according to each respective group Application will be facilitated using a microbrush spreading it over the entire lesion area for 30 seconds After the interventions patients will be instructed not to consume hard foods and to refrain from brushing their teeth for at least four hours following varnish application adhering to the manufacturers recommendations
Following all tests the data will undergo normality analysis Shapiro-Wilk test and homoscedasticity assessment Levenes test to determine the suitability of parametric statistics Therefore for all variables one-way ANOVA will be employed followed by Tukeys post-hoc test for group comparisons Demographic data will be evaluated using Pearsons chi-square test Friedmans test may be utilized for multiple comparisons sensitivity assessments and the Wilcoxon test for paired comparisons Analyses will be conducted using the statistical software SPSS 120 SPSS Inc Chicago IL USA All tests will be performed at a 95 confidence level α 005
For the diagnosis of MIH the investigators will employ the criteria outlined by the European Academy of Pediatric Dentistry which includes assessment of demarcated opacities post-eruptive enamel defects atypical restorations teeth lost due to MIH and incompletely erupted teeth The sample size was determined based on the anticipated outcome of pain reduction following treatment with an expected 60 reduction Calculation was conducted with a confidence level of 95 and a power of 80
Following the application of the inclusion and exclusion criteria each group will consist of a total of 88 teeth randomly assigned to one of four groups GI GII GIII and GIV The interventions for each group will be as follows
GI Low-Intensity Laser 1J 10 seconds Fluoride Varnish GII Low-Intensity Laser 1J 10 seconds Placebo GIII Low-Intensity Laser 2J 20 seconds Fluoride Varnish GIV Low-Intensity Laser 2J 20 seconds Placebo
To administer laser therapy the investigators will utilize a low-intensity infrared diode laser Therapy EC DMC Equipamentos Ltda São Carlos Brazil operating in continuous mode emitting at a wavelength of 808 nm with a power output of 100 mW The dosage will be set at either 1 or 2 Joules with a fluence of 35 Jcm2 Both the operator and the patient will wear personal protective equipment PPE during the procedure The tooth will be irradiated perpendicular to the tooth surface targeting the cervical third of the buccal surface both mesial and distal aspects as well as the center of the lesion Activation time will be either 10 or 20 seconds corresponding to 1 or 2 Joules respectively depending on the assigned group To ensure consistency even if the laser is activated for 1 Joule equivalent to 10 seconds the laser tip will be maintained in place for a standardized duration of 20 seconds the maximum activation time as confirmed by a stopwatch in all applications to ensure reliability
As an adjunct to LBI the investigators will use a fluoride varnish FV and a placebo varnish PV without the active ingredient ensuring that they are in identical packaging with the same taste and texture Both will maintain the same method of application The FV used will be Duraphat 22600 ppm F Colgate The application of both FV and PV will be conducted according to each respective group Application will be facilitated using a microbrush spreading it over the entire lesion area for 30 seconds After the interventions patients will be instructed not to consume hard foods and to refrain from brushing their teeth for at least four hours following varnish application adhering to the manufacturers recommendations
Following all tests the data will undergo normality analysis Shapiro-Wilk test and homoscedasticity assessment Levenes test to determine the suitability of parametric statistics Therefore for all variables one-way ANOVA will be employed followed by Tukeys post-hoc test for group comparisons Demographic data will be evaluated using Pearsons chi-square test Friedmans test may be utilized for multiple comparisons sensitivity assessments and the Wilcoxon test for paired comparisons Analyses will be conducted using the statistical software SPSS 120 SPSS Inc Chicago IL USA All tests will be performed at a 95 confidence level α 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FORP-USP | OTHER | UNIVERSITY OF SAO PAULO RIBEIRÃO PRETO FACULTY OF DENTISTRY | None |