Evaluation of the Effect of Non-Surgical Periodontal Treatment in Women With Polycystic Ovary Syndrome

NCT06567132 | Completed

• 1 other identifier: CYASAR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Is gum disease more common in women with PCOS?
2. 2.Does PCOS affect the response to gum disease treatment?
3. 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

Polycystic Ovary Syndrome; Gingivitis

Keywords

Annexin A1; Interleukin-6; Interleukin-10; Gingivitis; Polycystic ovary syndrome; Non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and sixth weeks after the treatment

Secondary Outcomes (3)

• Interleukin-6

  Baseline and sixth weeks after the treatment

• Interleukin-10

  Baseline and sixth weeks after the treatment

• Annexin A1

  Baseline and sixth weeks after the treatment

Study Arms (4)

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.

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.

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.

Interventions

Non-surgical periodontal treatment PROCEDURE

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.

Also known as: Scaling and root planing

PCOS and Gingivitis; Systemically healthy and Gingivitis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Since polycystic ovary syndrome is a hormonal disorder seen in women, only female participants were eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem University

Istanbul, Fatih, 34080, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 34664296 BACKGROUND

• Gonzalez 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 BACKGROUND

• Abraham 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 BACKGROUND

• Bostanci 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 BACKGROUND

• Akcali 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 RESULT

• Akcali 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 RESULT

• Akcali 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.

  PMID: 25712810 RESULT

• Ozcaka 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.

  PMID: 23327719 RESULT

• Ozcaka 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.

  PMID: 22509751 RESULT

• Dursun 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.

  PMID: 20800834 RESULT

• Tarkun 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.

  PMID: 18370758 RESULT

• Casarin 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.

  PMID: 36935103 RESULT

• Hassan 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.

  PMID: 29608211 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Gingivitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Sadiye Gunpinar, Assoc.Prof

  Affiliated

  STUDY DIRECTOR

• Cansu Can Yasar, Dr.

  Affiliated

  PRINCIPAL INVESTIGATOR

• Seda Ates, Prof.

  Affiliated

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person performing the biochemical analysis did not know the owner of the samples.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants included in the study were divided into four groups according to whether they had polycystic ovary syndrome and gingivitis.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: March 15, 2022
• Primary Completion: November 22, 2022
• Study Completion: February 8, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)