Clinical trial · Interventional
Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome
Evaluation of the Effect of Non-Surgical Periodontal Treatment on IL-6, IL-10 and ANXA-1 Levels in Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gingivitis | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-surgical periodontal treatment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- PCOS and Healthy Periodontium
- description
- Women who are diagnosed with PCOS and have healthy periodontium. Clinical periodontal indices, saliva and gingival crevicular fluid samples were obtained.
- type
- ACTIVE_COMPARATOR
- label
- PCOS and Gingivitis
- description
- 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.
- interventionNames
- Procedure: Non-surgical periodontal treatment
- type
- ACTIVE_COMPARATOR
- label
- Systemically healthy and Gingivitis
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (13)
- BACKGROUNDLeite 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. PMID 34664296
- BACKGROUNDGonzalez 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. PMID 22178787
- BACKGROUNDAbraham 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. PMID 33439300
- BACKGROUNDBostanci 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. PMID 20205380
- RESULTAkcali 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. PMID 28598286
- RESULTAkcali 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. PMID 25232962
- RESULTAkcali 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.