Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178042
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2023-09-18
Brief Title:
Effectiveness of MI Paste Plus and Remin Pro on Remineralization of Post-Orthodontic White Spot Lesions
Sponsor:
Izmir Katip Celebi University
Organization:
Izmir Katip Celebi University
Study Overview
Official Title:
Evaluation of the Efficiency of Different Remineralization Methods Used In the Treatment of Post-Orthodontic White Spot Lesions With Quantitative Light-Induced Fluorescence Method
Status:
COMPLETED
Status Verified Date:
2023-12
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:
One of the most undesired side effects of fixed orthodontic treatment is white spot lesions WSLs that appear on the buccal surface of teeth and cause aesthetic problems The aim of this prospective study was to quantitively evaluate the remineralization effect of casein phosphopeptide-amorphous calcium fluorophosphate CPP-ACFP containing MI Paste Plus and hydroxyapatite xylitol and fluoride containing Remin Pro agents in remineralizing post orthodontics white spots using Quantitive Light-Induced Fluorescence Method QLF and ICDAS II criteria compared to a control group in whom just a routine home care was instructed Thirty-nine individuals who had recently completed orthodontic treatment had at least one WSL on upper anterior teeth and aged between 12-25 years were included The participants were randomly assigned into three groups of 13 each 1 MI Paste Plus routine home care 2 Remin Pro routine home care and 3 routine home care control The treatment observation period was 12 weeks after bracket debonding Fluorescence loss F lesion area LA mm2 lesion volume Q mm2 maximum fluorescence loss Fmax ICDAS II criteria of WSLs were measured at beginning T0 and 4 T1 8 T2 and 12 T3 weeks later Statistical significance was set at p005
Detailed Description:
This randomized controlled trial was a parallel arm 1-1 allocations The study carried out in the Orthodontics Department Izmir Katip Celebi University Turkey The protocol of the trial was approved by the Izmir Katip Celebi University Research Ethics Committee A power analysis was carried out to provide that there was enough power to apply a statistical test of the research hypothesis to compare caries regression of Remin Pro to MI Paste Plus comparing with a control group in the remineralization of postorthodontic WSLs Patients who finished their fixed appliance treatment in the clinic of the Department of Orthodontics Faculty of Dentistry Izmir Katip Celebi University who were found to comply with the study criteria were informed Patients and parents who agreed to participate in the study signed an informed consent A total of 39 people 22 women and 17 men aged between 14 and 23 were included in the study with 13 people in each group Gender distribution and average age of the groups are similar Patients who are 12 to 25 years of age at least had 12 months of orthodontic treatment with braces at least had one upper anterior tooth with WSL included in the study Patient who are smoking with enamel hypoplasia or fluorosis with active periodontal disease with dentin caries with allergy to casein with previous bleaching excluded Simple randomization was performed at the start of the study using a random number table prepared using SPSS software version 260 New York USA for the allocation of patients who fulfilled all criteria and were willing to participate in this study Group I Patients were instructed to use MI Paste Plus GC Europe Leuven Belgium according to manufacturers instructions Group II Patients were instructed to use Remin Pro VOCO Cuxhaven Germany a pea-sized amount of the cream Group III Patients control group used a 1450 ppm fluoridated tooth paste Colgate Sensitive Pro-Relief Colgate-Palmolive Swidnica Poland for conventional tooth brushing and instructed to follow a routine home care The patients were evaluated at baseline T0 and every 30 days intervals for 3 months The primary outcome measures were assessment of mineral loss based on fluorescence loss measurements using QLF Lesions that scored 1 and 2 according to ICDAS II at debonding were included in the study The buccal surfaces of the teeth were examined and evaluated by light induced fluorescence intraoral camera QLF-D Biluminator Inspektor-Pro Amsterdam Holland for capturing fluorescent photographs in accordance with the manufacturers instructions Fluorescent images of the patient were evaluated in the White Spot Lesion option of the analysis program QA2v127 Following five QLF measurements were performed
1 Depth of lesion F shows the percentage of loss in fluorescence
2 Lesion area LA mm2 refers to the area covered by the demineralized area on the tooth
3 Lesion volume Q mm2 is derived from the combination of lesion area and lesion depth and represents the volume of the affected enamel
4 Maximum fluorescence loss Fmaxis related to depth of lesion and mineral loss Statistical analysis was performed with IBM SPSS version 26 SPSS Inc IBM Corporation NewYork USA Descriptive statistics are expressed as number of units n percent mean standard deviation x ss median M minimum min maximum max and interquartile range IQR values The normal distribution of the data was evaluated with the Shapiro Wilk test of normality Homogenicity of variances was evaluated with Levenes testThe concordance and differences in the first measurements and the second measurements were evaluated with the intra-class correlation coefficient and the paired samples t test The ages of the groups were compared with one-way analysis of variance The ΔF lesion area and ΔFmax values of the groups in T0 T1 T2 and T3 were compared with two-way analysis of variance in repeated measurements Bonferroni correction was applied in multiple comparisons ΔQ ICDAS II score and difference values from baseline were compared between groups by Kruskal-Wallis analysis In case of difference with Kruskal-Wallis analysis Dunn-Bonferroni test was used for multiple comparisons For ΔQ ICDAS II score Friedman analysis was performed for intragroup timepoint comparisons Bonferroni correction was applied in multiple comparisons for Friedman analysis Fisher Exact test was used to compare groups with categorical variables If the chi-square test result was found to be significant subgroup analyzes were performed with Bonferroni-corrected two-ratio z-test Statistical significance level was set at p005
1 Depth of lesion F shows the percentage of loss in fluorescence
2 Lesion area LA mm2 refers to the area covered by the demineralized area on the tooth
3 Lesion volume Q mm2 is derived from the combination of lesion area and lesion depth and represents the volume of the affected enamel
4 Maximum fluorescence loss Fmaxis related to depth of lesion and mineral loss Statistical analysis was performed with IBM SPSS version 26 SPSS Inc IBM Corporation NewYork USA Descriptive statistics are expressed as number of units n percent mean standard deviation x ss median M minimum min maximum max and interquartile range IQR values The normal distribution of the data was evaluated with the Shapiro Wilk test of normality Homogenicity of variances was evaluated with Levenes testThe concordance and differences in the first measurements and the second measurements were evaluated with the intra-class correlation coefficient and the paired samples t test The ages of the groups were compared with one-way analysis of variance The ΔF lesion area and ΔFmax values of the groups in T0 T1 T2 and T3 were compared with two-way analysis of variance in repeated measurements Bonferroni correction was applied in multiple comparisons ΔQ ICDAS II score and difference values from baseline were compared between groups by Kruskal-Wallis analysis In case of difference with Kruskal-Wallis analysis Dunn-Bonferroni test was used for multiple comparisons For ΔQ ICDAS II score Friedman analysis was performed for intragroup timepoint comparisons Bonferroni correction was applied in multiple comparisons for Friedman analysis Fisher Exact test was used to compare groups with categorical variables If the chi-square test result was found to be significant subgroup analyzes were performed with Bonferroni-corrected two-ratio z-test Statistical significance level was set at p005
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