Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804423
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-03-04
Brief Title:
Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Evaluation of the Efficacy of Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
Status:
COMPLETED
Status Verified Date:
2021-05
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:
None
Brief Summary:
This observational cohort study aims to evaluate the short-term 3 months efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth fluoride varnish application and further compare it to a different fluoride therapy utilizing a silver-containing fluoride agent combined with potassium iodide solution
Detailed Description:
A single trained investigator will screen for possible study participants of children aged 2-5 years old and their parents will be asked to participate in the study The participants will be consecutively recruited from regular clinic attendees of the Department of Preventive and Pediatric Dentistry at the University of Greifswald from whom present with active carious lesions ICDAS 5 along symptoms of hypersensitivity to be treated with fluoride varnish and further compared to participants treated with silver fluoride and potassium iodide application
Eligibility to the study will be determined by a single trained examiner through clinical findings of caries activity according to Bjørndal criteria and reported history of hypersensitivity symptoms obtained from the parentcaregiver of the participant followed by hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of the carious lesion to allocate areas with suspected dentin hypersensitivity
After clinical examination and obtainment of an informed consent eligible children will be treated with fluoride varnish application Duraphat or silver fluoride and potassium iodide application Riva Star according to manufacturers instructionsThe participants behavior shall be evaluated at the beginning during and after treatment Plaque Index API and Papillary Bleeding Index PBI will also be assessed prior to treatment and at the 3-months mark Procedures will be performed by six different dentists four pediatric specialists and two post-graduate pediatric dentistry students all of whom were briefed on the study protocol and received instructions in carrying in the interventions according to the manufacturers guide and their technical opinions regarding the performed procedures will be obtained following the procedure Follow up examinations after 3 months will be done by a single examiner Only one tooth per child will be included in the analysis
Data and information of this study will be recorded handled and stored in an organized and secure way to allow its accurate reporting interpretation and verification To assure confidentiality of clinical records an unambiguous subject identification code will be used Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty
All variables will be statistically analyzed using descriptive statistics plots and tests of normality Means and standard deviations SD will be calculated for all quantitative variables while frequencies and percentages will be calculated for categorical variables
Comparison between the two study groups will utilize independent samples t-test for quantitative normally distributed variables and Mann-Whitney U for quantitative non-normally distributed variables and qualitative ordinal variables Chi-squared and Fisher exact tests will be performed for comparing qualitative nominal variables between the two study groups Comparing the baseline and follow-up shall be done using paired t-test when the variable is normally distributed and Wilcoxon signed rank test when the variable is not normally distributed For comparing lesion activity before and after treatment McNemar test will be used and Friedman test for comparing the childrens behavior at 3 different time points before during and after treatment
A Significance will be set at p005 Data will be analyzed using IBM SPSS statistical software for windows version 25
Eligibility to the study will be determined by a single trained examiner through clinical findings of caries activity according to Bjørndal criteria and reported history of hypersensitivity symptoms obtained from the parentcaregiver of the participant followed by hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of the carious lesion to allocate areas with suspected dentin hypersensitivity
After clinical examination and obtainment of an informed consent eligible children will be treated with fluoride varnish application Duraphat or silver fluoride and potassium iodide application Riva Star according to manufacturers instructionsThe participants behavior shall be evaluated at the beginning during and after treatment Plaque Index API and Papillary Bleeding Index PBI will also be assessed prior to treatment and at the 3-months mark Procedures will be performed by six different dentists four pediatric specialists and two post-graduate pediatric dentistry students all of whom were briefed on the study protocol and received instructions in carrying in the interventions according to the manufacturers guide and their technical opinions regarding the performed procedures will be obtained following the procedure Follow up examinations after 3 months will be done by a single examiner Only one tooth per child will be included in the analysis
Data and information of this study will be recorded handled and stored in an organized and secure way to allow its accurate reporting interpretation and verification To assure confidentiality of clinical records an unambiguous subject identification code will be used Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty
All variables will be statistically analyzed using descriptive statistics plots and tests of normality Means and standard deviations SD will be calculated for all quantitative variables while frequencies and percentages will be calculated for categorical variables
Comparison between the two study groups will utilize independent samples t-test for quantitative normally distributed variables and Mann-Whitney U for quantitative non-normally distributed variables and qualitative ordinal variables Chi-squared and Fisher exact tests will be performed for comparing qualitative nominal variables between the two study groups Comparing the baseline and follow-up shall be done using paired t-test when the variable is normally distributed and Wilcoxon signed rank test when the variable is not normally distributed For comparing lesion activity before and after treatment McNemar test will be used and Friedman test for comparing the childrens behavior at 3 different time points before during and after treatment
A Significance will be set at p005 Data will be analyzed using IBM SPSS statistical software for windows version 25
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?:
False
Is an FDA AA801 Violation?:
None