NCT02633462

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

December 15, 2015

Last Update Submit

December 16, 2015

Conditions

Polycystic Ovary SyndromePeriodontitisInsulin Resistance

Outcome Measures

Primary Outcomes (2)

  • High Sensitivity C-Reactive Protein

    6 months

  • Insulin Resistance

    6 months

Study Arms (2)

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

Procedure: scaling and root planing , Myo-inositol

Control Group

ACTIVE COMPARATOR

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

Drug: Myo-inositol

Interventions

scaling and root planing , Myo-inositolPROCEDURE

scaling and root planing along with Myo-inositol supplementation (1 gm twice a day)

Also known as: SRP,Myo-inositol
Test Group
Myo-inositolDRUG

only provided treatment with Myo-inositol supplementation (1 gm twice a day)

Control Group

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromePeriodontitisInsulin Resistance

Interventions

Tooth ExfoliationRoot PlaningInositol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistrySugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 17, 2015

Record last verified: 2015-12