Impact of PCOS on Periodontal Status of Adolescent and Adult Age Group Women

NCT05113030 | Completed DMC

• 1 other identifier: swati PCOS perio
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women, primarily affecting the reproductive system, with substantial collateral negative health effects on metabolic, psychological, and cardiovascular functions. Patients with this syndrome are at higher risk of developing insulin resistance (IR), obesity, dyslipidemia, cardiovascular disease (CVD), and endometrial carcinoma.IR and hyperinsulinemia are responsible for the low-grade chronic systemic inflammation. Periodontitis, an immuno-inflammatory disease, is a result of interaction between bacterial attack and host inflammatory response, causing inflammation of supporting tissues of the teeth leading to tissue destruction and tooth loss. Chronic low-grade inflammation is emerging as a plausible etiologic mechanism linking periodontal disease and many systemic diseases. Previous cross-sectional studies described a possible relationship between PCOS and periodontitis and the impact of PCOS on gingival inflammation and vice-versa in terms of increased inflammatory markers (hsCRP, IL-6, IL-17 and TNF-α). In PCOS females, there is an alteration of various hormone levels in the body. Female sex steroid hormones play a key role in periodontal disease progression and periodontal and implant wound healing. Human gingiva has the capacity to metabolize hormones such as estrogen and progesterone. Moreover, gingival tissue exhibits receptors for such hormones and it is considered as a target organ for their direct action. These hormones might act on gingival cells by changing the effectiveness of the epithelial barrier to bacterial injury or by affecting the collagen maintenance and repair. To avoid periodontal implications as these hormonal changes can worsen the vulnerability to plaque-induced periodontal disease. So, present study is going to conduct in females with PCOS and periodontitis at different age groups like adolescent and adult age groups. AIM - Assessment of impact of polycystic ovary syndrome on periodontal status of women of adolescent and adult age groups.

Conditions

Polycystic Ovary Syndrome; Gingival Inflammation

Outcome Measures

Primary Outcomes (3)

• Bleeding on probing(BOP),

  BOP will recorded as 1 (present) if bleeding occur within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %

  6 months

• Probing pocket depth(PPD), in both the groups.

  The distance from the gingival margin to the base of the clinical pocket.

  6 months

• Serum hsCRP levels( high sensitivity C reactive proteins)

  Serum hsCRP levels were assessed using a kit with high sensitivity methodology in an auto-analyzer according to the manufacturer's instructions. The test principle was particle-enhanced immune-turbidimetric assay, in which human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies.

  6 months

Study Arms (2)

Test group(1st)

PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADOLESCENT AGE GROUP WILL BE ASSESSED

Other: PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADOLESCENT AGE GROUP WILL BE ASSESSED

Test group(2nd)

PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADULT AGE GROUP WILL BE ASSESSED

Other: PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADULT AGE GROUP WILL BE ASSESSED

Interventions

PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADOLESCENT AGE GROUP WILL BE ASSESSED OTHER

Test group(1st) enrollment criteria in PCOS group will be females of adolescent age newly diagnosed with PCOS, with \>16 natural teeth. The diagnosis of PCOS will be according to Rotterdam criteria, and periodontal parameters will be recorded to evaluate periodontal status

Test group(1st)

PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADULT AGE GROUP WILL BE ASSESSED OTHER

Test group(2 nd) enrollment criteria in PCOS group will be females of adult age newly diagnosed with PCOS, with \>16 natural teeth. The diagnosis of PCOS will be according to Rotterdam criteria, and periodontal parameters will be recorded to evaluate periodontal status

Test group(2nd)

Eligibility Criteria

• Age: 11 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

females of adolescent and adult age groups newly diagnosed with PCOS without taking treatment.

You may qualify if:

• females of adolescent and adult age groups newly diagnosed with PCOS(according to Rotterdam criteria), with \>16 natural teeth.
• age range (11-19Year) for adolescent age group
• age range (20-40Year) for adult age group..

You may not qualify if:

• Patients with any history of thyroid dysfunction, hyperprolactinemia and androgen-secreting tumors to avoid misdiagnosis of PCOS.
• Patients with chronic inflammatory disease such as nephrotic syndrome, chronic renal failure, significant cardiovascular disease, established type 1 or type 2 diabetes mellitus, or active cancer within the past 5 years will be excluded to control the confounders. With history of substance abuse (Tobacco/Alcohol) History of systemic antibiotics within 3 months Periodontal treatment within 6 months Aggressive periodontitis cases Females on oral contraceptive pills, pregnancy, lactation.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Gingivitis

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

Study Officials

• SWATI Jaglan

  Post graduate institute of dental sciences,Rohtak,Haryana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: November 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

IN (1)