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Non-surgical Periodontal Therapy and Myo-inositol in Polycystic Ovary Syndrome Women Having Chronic Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02633462
Recruitment Status : Unknown
Verified December 2015 by Postgraduate Institute of Dental Sciences Rohtak.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Information provided by (Responsible Party):
Postgraduate Institute of Dental Sciences Rohtak

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Periodontitis Insulin Resistance Procedure: scaling and root planing , Myo-inositol Drug: Myo-inositol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arm Intervention/treatment
Active Comparator: Test Group
Polycystic ovarian syndrome(PCOS) women who have periodontitis and treated with scaling and root planing(SRP) along with Myo-inositol supplementation
Procedure: scaling and root planing , Myo-inositol
scaling and root planing along with Myo-inositol supplementation (1 gm twice a day)
Other Name: SRP,Myo-inositol

Active Comparator: Control Group
Polycystic ovarian syndrome(PCOS) women who have periodontitis treated with Myo-inositol along with oral hygiene instructions.
Drug: Myo-inositol
only provided treatment with Myo-inositol supplementation (1 gm twice a day)

Primary Outcome Measures :
  1. High Sensitivity C-Reactive Protein [ Time Frame: 6 months ]
  2. Insulin Resistance [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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Responsible Party: Postgraduate Institute of Dental Sciences Rohtak Identifier: NCT02633462     History of Changes
Other Study ID Numbers: Deepti perio PGIDS/IEC/2015/60
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Insulin Resistance
Polycystic Ovary Syndrome
Chronic Periodontitis
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs