Polycystic Ovary SyndromeNCT06567132
Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome
A study testing Non-surgical periodontal treatment in people with Polycystic Ovary Syndrome and Gingivitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Gingivitis
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 with polycystic ovary syndrome and healthy periodontium
- Women aged 18-40 with polycystic ovary syndrome and gingivitis
- Women aged 18-40 who are systemically healthy and have gingivitis
- Women aged 18-40 who are systemically healthy and have a healthy periodontium
- Presence of at least 20 permanent teeth
Who cannot join
- Receiving anti-inflammatory or antimicrobial therapy in the past three months
- Smoking and alcohol consumption
- Body mass index > 30 kg/m2
- Individuals with diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid disorders, Cushing's syndrome, hypertension, liver or kidney dysfunction
- Medication that may affect metabolic criteria, such as oral contraceptive agents, any steroid hormone or related preparations, hypertensive drugs and insulin sensitizing drugs
- Pregnancy and breastfeeding
Show all 9Show fewer
- Receiving periodontal treatment in the last 6 months
- Taking any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, coumadin, steroidal non-anti-inflammatory drugs, aspirin > 81 mg)
- Active infectious diseases such as hepatitis, HIV or tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- Is gum disease more common in women with PCOS?
- Does PCOS affect the response to gum disease treatment?
- 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.
Read the 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 45.12 and 82.94, respectively, and standard deviations as 37.46 and 13.59, respectively, the sample size for a 95% confidence level and 80% power at a 0.05 significance level was calculated as 15 people per group and n=60 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, n=20), b) PCOSG (diagnosed with PCOS and gingivitis, n=20), c) SG (systemically healthy individuals with gingivitis, n=20), and d) SPS (systemically healthy individuals with healthy periodontium, n=20). 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 26.0 program at a significance level of 0.05 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 12.3 to determine the distinctiveness of the ANXA1 variant.
- Conditions
- Polycystic Ovary Syndrome, Gingivitis
- Being tested
- Non-surgical periodontal treatment
- Keywords
- Annexin A1, Interleukin-6, Interleukin-10, Gingivitis, Polycystic ovary syndrome, Non-surgical periodontal treatment
- Medical subject headings
- Polycystic Ovary Syndrome, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Also called Scaling and root planing
Non-surgical periodontal treatment was performed in a single session using an ultrasonic device and a manual scaler. Polishing was done using polishing paste and rubber cup. Clinical periodontal indices, saliva and gingival crevicular samples were repeated after six weeks follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| PCOS and Healthy Periodontium | No intervention | Women who are diagnosed with PCOS and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. |
| PCOS and Gingivitis | Active comparator | Women who are diagnosed with PCOS and have gingivitis.Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed. Receives: Procedure: Non-surgical periodontal treatment |
| Systemically healthy and Gingivitis | Active comparator | Women who are systemically healthy and have gingivitis. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed. Receives: Procedure: Non-surgical periodontal treatment |
| Systemically and Periodontally Healthy | No intervention | Women who are systemically healthy and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Bleeding on probing is an important indicator of gingivitis. Bleeding on probing less than 10% is an indicator of healthy periodontium and means that the non-surgical periodontal treatment is successful.
Measured: Baseline and sixth weeks after the treatment
Secondary outcomes (3)
Interleukin-6
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Measured: Baseline and sixth weeks after the treatment
Interleukin-10
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Measured: Baseline and sixth weeks after the treatment
Annexin A1
Comparisons between groups were made by evaluating baseline and post-treatment levels.
Measured: Baseline and sixth weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Mar 2022
- Primary completion22 Nov 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants included in the study were divided into four groups according to whether they had polycystic ovary syndrome and gingivitis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadiye Gunpinar, Assoc.Prof, Study director, AffiliatedCansu Can Yasar, Dr., Principal investigator, AffiliatedSeda Ates, Prof., Study chair, Affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567132
- Sponsor's protocol ID
- CYASAR
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data could be shared if requested.
Publications
Leite FRM, Nascimento GG, Moller HJ, Belibasakis GN, Bostanci N, Smith PC, Lopez R. Cytokine profiles and the dynamic of gingivitis development in humans. J Clin Periodontol. 2022 Jan;49(1):67-75. doi: 10.1111/jcpe.13565. Epub 2021 Oct 27.
PubMed 34664296Gonzalez F. Inflammation in Polycystic Ovary Syndrome: underpinning of insulin resistance and ovarian dysfunction. Steroids. 2012 Mar 10;77(4):300-5. doi: 10.1016/j.steroids.2011.12.003. Epub 2011 Dec 8.
PubMed 22178787Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.
PubMed 33439300Bostanci N, Heywood W, Mills K, Parkar M, Nibali L, Donos N. Application of label-free absolute quantitative proteomics in human gingival crevicular fluid by LC/MS E (gingival exudatome). J Proteome Res. 2010 May 7;9(5):2191-9. doi: 10.1021/pr900941z.
PubMed 20205380Akcali A, Bostanci N, Ozcaka O, Gumus P, Ozturk-Ceyhan B, Tervahartiala T, Husu H, Buduneli N, Sorsa T, Belibasakis GN. Gingival Inflammation and Salivary or Serum Granulocyte-Secreted Enzymes in Patients With Polycystic Ovary Syndrome. J Periodontol. 2017 Nov;88(11):1145-1152. doi: 10.1902/jop.2017.170043. Epub 2017 Jun 9.
PubMed 28598286Akcali A, Bostanci N, Ozcaka O, Ozturk-Ceyhan B, Gumus P, Buduneli N, Belibasakis GN. Association between polycystic ovary syndrome, oral microbiota and systemic antibody responses. PLoS One. 2014 Sep 18;9(9):e108074. doi: 10.1371/journal.pone.0108074. eCollection 2014.
PubMed 25232962Akcali A, Bostanci N, Ozcaka O, Ozturk-Ceyhan B, Gumus P, Tervahartiala T, Husu H, Buduneli N, Sorsa T, Belibasakis GN. Elevated matrix metalloproteinase-8 in saliva and serum in polycystic ovary syndrome and association with gingival inflammation. Innate Immun. 2015 Aug;21(6):619-25. doi: 10.1177/1753425915572172. Epub 2015 Feb 23.
PubMed 25712810Ozcaka O, Buduneli N, Ceyhan BO, Akcali A, Hannah V, Nile C, Lappin DF. Is interleukin-17 involved in the interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2013 Dec;84(12):1827-37. doi: 10.1902/jop.2013.120483. Epub 2013 Jan 17.
PubMed 23327719Ozcaka O, Ceyhan BO, Akcali A, Bicakci N, Lappin DF, Buduneli N. Is there an interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2012 Dec;83(12):1529-37. doi: 10.1902/jop.2012.110588. Epub 2012 Apr 17.
PubMed 22509751Dursun E, Akalin FA, Guncu GN, Cinar N, Aksoy DY, Tozum TF, Kilinc K, Yildiz BO. Periodontal disease in polycystic ovary syndrome. Fertil Steril. 2011 Jan;95(1):320-3. doi: 10.1016/j.fertnstert.2010.07.1052.
PubMed 20800834Tarkun I, Cetinarslan B, Turemen E, Canturk Z, Biyikli M. Association between Circulating Tumor Necrosis Factor-Alpha, Interleukin-6, and Insulin Resistance in Normal-Weight Women with Polycystic Ovary Syndrome. Metab Syndr Relat Disord. 2006 Summer;4(2):122-8. doi: 10.1089/met.2006.4.122.
PubMed 18370758Casarin RCV, Salmon CR, Stolf CS, Paz HES, Rangel TP, Domingues RR, Pauletti BA, Paes-Leme AF, Araujo C, Santamaria MP, Ruiz KS, Monteiro MF. Salivary annexin A1: A candidate biomarker for periodontitis. J Clin Periodontol. 2023 Jul;50(7):942-951. doi: 10.1111/jcpe.13803. Epub 2023 Mar 19.
PubMed 36935103Hassan MN, Belibasakis GN, Gumus P, Ozturk VO, Emingil G, Bostanci N. Annexin-1 as a salivary biomarker for gingivitis during pregnancy. J Periodontol. 2018 Jul;89(7):875-882. doi: 10.1002/JPER.17-0557.
PubMed 29608211
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06567132
- Acronym / sponsor ID
- CYASAR
- Conditions
- Polycystic Ovary Syndrome, Gingivitis
- Keywords
- Annexin A1, Interleukin-6, Interleukin-10, Gingivitis, Polycystic ovary syndrome, Non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is gum disease more common in women with PCOS?
- Does PCOS affect the response to gum disease treatment?
- 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 45.12 and 82.94, respectively, and standard deviations as 37.46 and 13.59, respectively, the sample size for a 95% confidence level and 80% power at a 0.05 significance level was calculated as 15 people per group and n=60 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, n=20), b) PCOSG (diagnosed with PCOS and gingivitis, n=20), c) SG (systemically healthy individuals with gingivitis, n=20), and d) SPS (systemically healthy individuals with healthy periodontium, n=20). 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 26.0 program at a significance level of 0.05 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 12.3 to determine the distinctiveness of the ANXA1 variant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants included in the study were divided into four groups according to whether they had polycystic ovary syndrome and gingivitis.
| Arm | Type | Receives |
|---|---|---|
| PCOS and Healthy Periodontium | No intervention | –Women who are diagnosed with PCOS and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. |
| PCOS and Gingivitis | Active comparator | Procedure: Non-surgical periodontal treatmentWomen who are diagnosed with PCOS and have gingivitis.Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed. |
| Systemically healthy and Gingivitis | Active comparator | Procedure: Non-surgical periodontal treatmentWomen who are systemically healthy and have gingivitis. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. Non-surgical periodontal treatment was performed. |
| Systemically and Periodontally Healthy | No intervention | –Women who are systemically healthy and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-40 with polycystic ovary syndrome and healthy periodontium
- Women aged 18-40 with polycystic ovary syndrome and gingivitis
- Women aged 18-40 who are systemically healthy and have gingivitis
- Women aged 18-40 who are systemically healthy and have a healthy periodontium
- Presence of at least 20 permanent teeth
Key exclusion criteria (9 listed)
- Receiving anti-inflammatory or antimicrobial therapy in the past three months
- Smoking and alcohol consumption
- Body mass index > 30 kg/m2
- Individuals with diabetes mellitus, hyperprolactinemia, congenital adrenal hyperplasia, androgen-secreting tumors, thyroid disorders, Cushing's syndrome, hypertension, liver or kidney dysfunction
- Medication that may affect metabolic criteria, such as oral contraceptive agents, any steroid hormone or related preparations, hypertensive drugs and insulin sensitizing drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal treatmentAlso: Scaling and root planingNon-surgical periodontal treatment was performed in a single session using an ultrasonic device and a manual scaler. Polishing was done using polishing paste and rubber cup. Clinical periodontal indices, saliva and gingival crevicular samples were repeated after six weeks follow-up period. | Procedure or surgery | PCOS and Gingivitis, Systemically healthy and Gingivitis |
Primary outcome
Bleeding on probing
Time frame: Baseline and sixth weeks after the treatment
Bleeding on probing is an important indicator of gingivitis. Bleeding on probing less than 10% is an indicator of healthy periodontium and means that the non-surgical periodontal treatment is successful.
3 secondary outcomes
Interleukin-6
Time frame: Baseline and sixth weeks after the treatment
Interleukin-10
Time frame: Baseline and sixth weeks after the treatment
Annexin A1
Time frame: Baseline and sixth weeks after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 34664296Leite FRM, Nascimento GG, Moller HJ, Belibasakis GN, Bostanci N, Smith PC, Lopez R. Cytokine profiles and the dynamic of gingivitis development in humans. J Clin Periodontol. 2022 Jan;49(1):67-75. doi: 10.1111/jcpe.13565. Epub 2021 Oct 27.
- Background: PubMed 22178787Gonzalez F. Inflammation in Polycystic Ovary Syndrome: underpinning of insulin resistance and ovarian dysfunction. Steroids. 2012 Mar 10;77(4):300-5. doi: 10.1016/j.steroids.2011.12.003. Epub 2011 Dec 8.
- Background: PubMed 33439300Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.
- Background: PubMed 20205380Bostanci N, Heywood W, Mills K, Parkar M, Nibali L, Donos N. Application of label-free absolute quantitative proteomics in human gingival crevicular fluid by LC/MS E (gingival exudatome). J Proteome Res. 2010 May 7;9(5):2191-9. doi: 10.1021/pr900941z.
- Results publication: PubMed 28598286Akcali A, Bostanci N, Ozcaka O, Gumus P, Ozturk-Ceyhan B, Tervahartiala T, Husu H, Buduneli N, Sorsa T, Belibasakis GN. Gingival Inflammation and Salivary or Serum Granulocyte-Secreted Enzymes in Patients With Polycystic Ovary Syndrome. J Periodontol. 2017 Nov;88(11):1145-1152. doi: 10.1902/jop.2017.170043. Epub 2017 Jun 9.
- Results publication: PubMed 25232962Akcali A, Bostanci N, Ozcaka O, Ozturk-Ceyhan B, Gumus P, Buduneli N, Belibasakis GN. Association between polycystic ovary syndrome, oral microbiota and systemic antibody responses. PLoS One. 2014 Sep 18;9(9):e108074. doi: 10.1371/journal.pone.0108074. eCollection 2014.
- Results publication: PubMed 25712810Akcali A, Bostanci N, Ozcaka O, Ozturk-Ceyhan B, Gumus P, Tervahartiala T, Husu H, Buduneli N, Sorsa T, Belibasakis GN. Elevated matrix metalloproteinase-8 in saliva and serum in polycystic ovary syndrome and association with gingival inflammation. Innate Immun. 2015 Aug;21(6):619-25. doi: 10.1177/1753425915572172. Epub 2015 Feb 23.
- Results publication: PubMed 23327719Ozcaka O, Buduneli N, Ceyhan BO, Akcali A, Hannah V, Nile C, Lappin DF. Is interleukin-17 involved in the interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2013 Dec;84(12):1827-37. doi: 10.1902/jop.2013.120483. Epub 2013 Jan 17.
- Results publication: PubMed 22509751Ozcaka O, Ceyhan BO, Akcali A, Bicakci N, Lappin DF, Buduneli N. Is there an interaction between polycystic ovary syndrome and gingival inflammation? J Periodontol. 2012 Dec;83(12):1529-37. doi: 10.1902/jop.2012.110588. Epub 2012 Apr 17.
- Results publication: PubMed 20800834Dursun E, Akalin FA, Guncu GN, Cinar N, Aksoy DY, Tozum TF, Kilinc K, Yildiz BO. Periodontal disease in polycystic ovary syndrome. Fertil Steril. 2011 Jan;95(1):320-3. doi: 10.1016/j.fertnstert.2010.07.1052.
- Results publication: PubMed 18370758Tarkun I, Cetinarslan B, Turemen E, Canturk Z, Biyikli M. Association between Circulating Tumor Necrosis Factor-Alpha, Interleukin-6, and Insulin Resistance in Normal-Weight Women with Polycystic Ovary Syndrome. Metab Syndr Relat Disord. 2006 Summer;4(2):122-8. doi: 10.1089/met.2006.4.122.
- Results publication: PubMed 36935103Casarin RCV, Salmon CR, Stolf CS, Paz HES, Rangel TP, Domingues RR, Pauletti BA, Paes-Leme AF, Araujo C, Santamaria MP, Ruiz KS, Monteiro MF. Salivary annexin A1: A candidate biomarker for periodontitis. J Clin Periodontol. 2023 Jul;50(7):942-951. doi: 10.1111/jcpe.13803. Epub 2023 Mar 19.
- Individual participant dataSharing planned: No. Data could be shared if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadiye Gunpinar, Assoc.Prof study director
Affiliated
Cansu Can Yasar, Dr. principal investigator
Affiliated
Seda Ates, Prof. study chair
Affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal treatment in people with Polycystic Ovary Syndrome and Gingivitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on probing (time frame: Baseline and sixth weeks after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567132, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.