Impact of Polycystic Ovary Syndrome on Periodontal Status of Women of Adolescent and Adult Age Groups: A Cross Sectional Study
Sponsor study identifier
observational
100
1 country
1
Study Start
November 1, 2021
Actual (reported)Primary Completion
June 15, 2022
Actual (reported)Study Completion
June 15, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2021
Actual (reported)November 1, 2021
Actual (reported)November 9, 2021
Actual (reported)June 15, 2022
Actual (reported)June 15, 2022
Actual (reported)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
PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADOLESCENT AGE GROUP WILL BE ASSESSED
PERIODONTAL STATUS OF FEMALE PATIENTS WITH PCOS (NEWLY DIAGNOSED) OF ADULT AGE GROUP WILL BE ASSESSED
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
females of adolescent and adult age groups newly diagnosed with PCOS without taking treatment.
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
SWATI Jaglan
Post graduate institute of dental sciences,Rohtak,Haryana
100 participants (actual enrollment reported by the registry).
First Submitted
October 28, 2021
First Posted
November 9, 2021
Study Start
November 1, 2021
Actual (reported)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
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Primary Completion
June 15, 2022
Actual (reported)Study Completion
June 15, 2022
Actual (reported)Last Updated
April 25, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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