Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567132
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effect of Non-Surgical Periodontal Treatment on IL-6 IL-10 and ANXA-1 Levels in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to compare women with polycystic ovary syndrome and systemically healthy woman in relation to their gums and gum treatment outcomes as well as to investigate the role of a new biomarker in gum disease The main questions it aims to answer are
1 Is gum disease more common in women with PCOS
2 Does PCOS affect the response to gum disease treatment
3 Is there a new marker to identify gum disease It is known that polycystic ovary syndrome is a low-grade chronic inflammatory disease It has been reported that this aspect may be associated with gum disease In our study women with polycystic ovary syndrome will be compared with systemic healthy women Initial gum conditions and response after treatment will be investigated Additionally the results will be supported by gingival crevicular fluid and saliva analysis
1 Is gum disease more common in women with PCOS
2 Does PCOS affect the response to gum disease treatment
3 Is there a new marker to identify gum disease It is known that polycystic ovary syndrome is a low-grade chronic inflammatory disease It has been reported that this aspect may be associated with gum disease In our study women with polycystic ovary syndrome will be compared with systemic healthy women Initial gum conditions and response after treatment will be investigated Additionally the results will be supported by gingival crevicular fluid and saliva analysis
Detailed Description:
Polycystic ovary syndrome PCOS is an endocrine disorder characterized by hyperandrogenism polycystic ovaries and ovulatory dysfunction affecting 4-21 of women worldwide It has been shown that PCOS has an impact on both local and systemic proinflammatory markers along with periodontal disease but the relationship between them remains unclear The aim of this study is to compare the clinical and biochemical response to periodontal treatment between individuals with PCOS and gingival inflammation and those with systemic health as well as to investigate the role of annexin-1 ANXA1 biomarker in gingival inflammation
Taking previous studies as a reference and considering the bleeding on probing variable as 4512 and 8294 respectively and standard deviations as 3746 and 1359 respectively the sample size for a 95 confidence level and 80 power at a 005 significance level was calculated as 15 people per group and n60 in total Considering that participants may drop out of the study the sample size was determined as 20 people per group and n 80 people in total
A total of 80 participants were included 40 individuals diagnosed with PCOS and 40 systemically healthy volunteers Following periodontal examinations of all individuals they were divided into four groups a PCOSPS diagnosed with PCOS and healthy periodontium n20 b PCOSG diagnosed with PCOS and gingivitis n20 c SG systemically healthy individuals with gingivitis n20 and d SPS systemically healthy individuals with healthy periodontium n20 After gynecological and ultrasonographic examinations as well as recording anthropometric measurements of all participants hormonal tests were analysed For the evaluation of periodontal status clinical periodontal measurements were taken at the beginning of the study and at the 6th week after non-surgical periodontal treatment NSPT in the gingivitis groups Gingival crevicular fluid GCF and saliva samples were collected at the beginning of the study and repeated at the 6th week after NSPT to assess the levels of interleukin-6 IL-6 IL-10 and ANXA1 Biochemical analysis of all samples was performed using the enzyme-linked immunosorbent assay ELISA method
An identification form was prepared to keep participants records including their personal and contact information Gingival crevicular fluid tracking form to record when the gingival fluid samples were taken which participant they belonged to and from which dental area they were taken saliva sample tracking form to record when the saliva samples were taken and which participant they belong to periodontal index form to record plaque score bleeding on probing gingival pocket depth gingival recession and attachment level during periodontal examination polycystic ovary syndrome form containing the participants medical information and a modified Ferriman-Gallwey score form was prepared to determine and record the degree of hirsutism
Statistical analysis of the data obtained as a result of the study was performed in the IBM SPSS Statistics 260 program at a significance level of 005 and a confidence level of 95 The distribution of the data was examined with the Shapiro-Wilk test Comparisons between four independent groups with normal distribution were made with the One Way Anova test and comparisons between four independent groups with non-normal distribution were made with the Kruskal Wallis test Variables that were significant as a result of four group comparisons were compared with the Dunn-Bonferroni post-hoc test If the variables met the assumption of normal distribution comparisons between two independent groups were made with the Independent Sample t test Chi-Square test or Fisher-Freeman-Halton test was used to evaluate the difference between categorical variables In examining the relationship between numerical variables Spearman non-normally distributed and Pearson normally distributed correlation coefficients were evaluated The changes in time-dependent variables within and between groups were examined with the Repeated Anova test While the descriptive statistics of the data were explained as mean and standard deviation or median minimum-maximum the descriptive statistics of categorical variables were given as frequency ROC Receiver Operating Characteristics curve analysis was performed using Medcalc Version 123 to determine the distinctiveness of the ANXA1 variant
Taking previous studies as a reference and considering the bleeding on probing variable as 4512 and 8294 respectively and standard deviations as 3746 and 1359 respectively the sample size for a 95 confidence level and 80 power at a 005 significance level was calculated as 15 people per group and n60 in total Considering that participants may drop out of the study the sample size was determined as 20 people per group and n 80 people in total
A total of 80 participants were included 40 individuals diagnosed with PCOS and 40 systemically healthy volunteers Following periodontal examinations of all individuals they were divided into four groups a PCOSPS diagnosed with PCOS and healthy periodontium n20 b PCOSG diagnosed with PCOS and gingivitis n20 c SG systemically healthy individuals with gingivitis n20 and d SPS systemically healthy individuals with healthy periodontium n20 After gynecological and ultrasonographic examinations as well as recording anthropometric measurements of all participants hormonal tests were analysed For the evaluation of periodontal status clinical periodontal measurements were taken at the beginning of the study and at the 6th week after non-surgical periodontal treatment NSPT in the gingivitis groups Gingival crevicular fluid GCF and saliva samples were collected at the beginning of the study and repeated at the 6th week after NSPT to assess the levels of interleukin-6 IL-6 IL-10 and ANXA1 Biochemical analysis of all samples was performed using the enzyme-linked immunosorbent assay ELISA method
An identification form was prepared to keep participants records including their personal and contact information Gingival crevicular fluid tracking form to record when the gingival fluid samples were taken which participant they belonged to and from which dental area they were taken saliva sample tracking form to record when the saliva samples were taken and which participant they belong to periodontal index form to record plaque score bleeding on probing gingival pocket depth gingival recession and attachment level during periodontal examination polycystic ovary syndrome form containing the participants medical information and a modified Ferriman-Gallwey score form was prepared to determine and record the degree of hirsutism
Statistical analysis of the data obtained as a result of the study was performed in the IBM SPSS Statistics 260 program at a significance level of 005 and a confidence level of 95 The distribution of the data was examined with the Shapiro-Wilk test Comparisons between four independent groups with normal distribution were made with the One Way Anova test and comparisons between four independent groups with non-normal distribution were made with the Kruskal Wallis test Variables that were significant as a result of four group comparisons were compared with the Dunn-Bonferroni post-hoc test If the variables met the assumption of normal distribution comparisons between two independent groups were made with the Independent Sample t test Chi-Square test or Fisher-Freeman-Halton test was used to evaluate the difference between categorical variables In examining the relationship between numerical variables Spearman non-normally distributed and Pearson normally distributed correlation coefficients were evaluated The changes in time-dependent variables within and between groups were examined with the Repeated Anova test While the descriptive statistics of the data were explained as mean and standard deviation or median minimum-maximum the descriptive statistics of categorical variables were given as frequency ROC Receiver Operating Characteristics curve analysis was performed using Medcalc Version 123 to determine the distinctiveness of the ANXA1 variant
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