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临床试验/NCT02633462
NCT02633462Unknown2 期

Effect of Non-surgical Periodontal Therapy Along With Myo-inositol on High Sensitivity C-reactive Protein and Insulin Resistance in Polycystic Ovary Syndrome Women Having Chronic Periodontitis: A Randomized Controlled Trial

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 56 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
56
主要终点
High Sensitivity C-Reactive Protein

研究概览

简要总结

The Purpose of this study is to assess the correlation between the inflammatory periodontal status and the medical treatment status in Polycystic Ovary Syndrome(PCOS) women with systemic inflammation and to evaluate the effect of non-surgical periodontal therapy in the form of scaling and root planing along with medical treatment on the level of serological marker of inflammation (High sensitivity-C Reactive Protein) and insulin resistance in PCOS women with chronic periodontitis.

详细描述

Polycystic Ovary Syndrome(PCOS) is a genetically complex endocrine disorder of uncertain etiology and a common cause of hyperandrogenism, anovulatory infertility, menstrual dysfunction, hirsutism, alopecia and acne. It was first reported by Stein and Leventhal in 1935. It affects 6-8% of women of reproductive age. Accordingly PCOS might be viewed as a gender specific form of metabolic syndrome.

According to Androgen Excess Society(AES) /2006 criteria PCOS was defined by the presence of hyperandrogenism (clinical and/or biochemical),Oligo or anovulation, Polycystic ovarian morphology(PCOM)- at least one ovary with 1)12 or more follicles (2-9 mm in diameter) or 2) Ovarian volume >10 ml. Patients with PCOS are at higher risk of developing cardiovascular risk factors that is diabetes, insulin resistance, visceral obesity and a state of low grade inflammation.Therefore, PCOS may represent a model for studying the complex interaction among these Cardiovascular risk factors,especially chronic inflammation and insulin resistance.

Visceral obesity,insulin resistance and hyperinsulinemia are prevalent co-morbidities of PCOS which promotes androgen excess.Insulin resistance in PCOS is due to a post-receptor defect in insulin receptor mediated cells which leads to induce a decrease in glucose transporters. Therefore, reduction of insulin secretion and/or improvement of its action at target tissues offer the possibility of improving the effects of androgen excess by correction of the reproductive dysfunction and preventing metabolic derangements from becoming entrenched.

For this purpose many insulin-sensitizing agents like metformin have been tried as a treatment modality of metabolic as well as reproductive dysfunction in PCOS.Myo-inositol (MI) is a naturally occurring substance produced in the human body that belongs to the vitamin B complex group.PCOS has been linked to a deficiency in myo-inositol. MI can be synthesized by the body from food, but when the investigators are already deficient, the lack of MI can impact the ability of the body to be sensitive to insulin. MI plays an important role as the structural basis for a number of secondary messengers including synthesis of phosphatidylinositol 3-kinase (PI 3-kinase), a key messenger to improve insulin sensitivity and thereby reducing insulin resistance Supplying extra MI appears to temporarily correct the impaired insulin pathways and reduce the signs and symptoms of insulin resistance.

Periodontal diseases, including gingivitis are common chronic infectious diseases characterized by a gingival inflammatory response against predominantly pathogenic microorganisms that colonize the subgingival area and cause local and systemic elevations of proinflammatory cytokines, such as tumor necrosis factor-a and interleukin-6 resulting in loss of connective tissue attachment, alveolar bone resorption which can result in tooth loss. It is well established that patients suffering from periodontitis present with a low grade systemic inflammatory state when compared with healthy subjects.Increased concentrations of inflammatory biomarkers in both gingival tissues and serum such as C-reactive protein and interleukin have been reported.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Females of reproductive age group (15-35 yrs)
  • Subjects diagnosed with PCOS according to AES (Androgen Excess Society)/2006 criteria:
  • Presence of hyperandrogenism (clinical and/or biochemical)
  • Oligo or anovulation
  • PCOM (Polycystic ovarian morphology)- at least one ovary with 1)12 or more follicles (2-9 mm in diameter) or 2) Ovarian volume >10 ml
  • Presence of ≥20 natural teeth
  • Patients having Chronic Periodontitis will be defined according to division of Oral Health at the Centers for Disease Control and Prevention (CDC) in collaboration with American Academy of Periodontology (AAP) Moderate periodontitis: ≥ 2 interproximal sites with AL, ≥4 mm (not on same tooth), or ≥2 interproximal sites with PD ≥5 mm (not on same tooth) (Page and Eke 2007)

排除标准

  • Any history of thyroid dysfunction, hyperprolactinemia, androgen -secreting tumour, nephrotic syndrome, chronic renal failure.
  • Significant cardiovascular disease.
  • Established type 1 or type 2 diabetes mellitus.
  • Active cancer within the last past 5 yrs.
  • Smokers and alcoholic subjects.
  • History of systemic antibiotics or oral contraceptives usage within last 3 months.
  • Periodontal treatment within 6 months prior to study

研究组 & 干预措施

Test Group

Active Comparator

Polycystic ovarian syndrome(PCOS) women who have periodontitis and treated with scaling and root planing(SRP) along with Myo-inositol supplementation

干预措施: scaling and root planing , Myo-inositol (Procedure)

Control Group

Active Comparator

Polycystic ovarian syndrome(PCOS) women who have periodontitis treated with Myo-inositol along with oral hygiene instructions.

干预措施: Myo-inositol (Drug)

结局指标

主要结局

High Sensitivity C-Reactive Protein

时间窗: 6 months

Insulin Resistance

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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