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Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis (EPRNPPMP)

Primary Purpose

Periodontitis, Menopause, Plaque

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
scaling and root planing (srp)
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring Non Surgical Therapy

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:Patients should have at least 15 natural teeth remaining

  • Non smokers
  • Systemically healthy from past 6 months

Exclusion Criteria:Present or past smokers

  • Below 40 years of age
  • With gross oral pathology or tumors
  • Patients on long term steroid medication
  • Undergoing Hormone replacement therapy (HRT)
  • Pregnant women or planning for pregnancy
  • Those who have received periodontal therapy in the preceding 6 months
  • Those that are under medication in the preceding 6 months
  • Any systemic disorders or any medication that affects the periodontal status was excluded from this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    pre menopause with periodontitis

    post menopause with periodontitis

    Arm Description

    non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)

    non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)

    Outcomes

    Primary Outcome Measures

    Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis
    pocket depth reduction calculated with PRI index
    Evaluation of periodontal response to non surgical therapy in pre and post menopausal
    plaque scores was calculated with Silness and Loe index

    Secondary Outcome Measures

    Full Information

    First Posted
    March 11, 2016
    Last Updated
    March 18, 2016
    Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02718014
    Brief Title
    Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis
    Acronym
    EPRNPPMP
    Official Title
    Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The present study was evaluated periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.
    Detailed Description
    AIM: The aim of the present study was to evaluate periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy. MATERIALS AND METHODS: Periodontal status was measured by Periodontal index (PRI), and oral hygiene status was measured by plaque index (PI). Both the parameters were measured at baseline i.e before Scaling and Root Planing (SRP) and after 3 months intervals post treatment. SRP was done in both pre&post menopause groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis, Menopause, Plaque, Inflammation
    Keywords
    Non Surgical Therapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pre menopause with periodontitis
    Arm Type
    Other
    Arm Description
    non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)
    Arm Title
    post menopause with periodontitis
    Arm Type
    Other
    Arm Description
    non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)
    Intervention Type
    Other
    Intervention Name(s)
    scaling and root planing (srp)
    Primary Outcome Measure Information:
    Title
    Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis
    Description
    pocket depth reduction calculated with PRI index
    Time Frame
    3 months
    Title
    Evaluation of periodontal response to non surgical therapy in pre and post menopausal
    Description
    plaque scores was calculated with Silness and Loe index
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Patients should have at least 15 natural teeth remaining Non smokers Systemically healthy from past 6 months Exclusion Criteria:Present or past smokers Below 40 years of age With gross oral pathology or tumors Patients on long term steroid medication Undergoing Hormone replacement therapy (HRT) Pregnant women or planning for pregnancy Those who have received periodontal therapy in the preceding 6 months Those that are under medication in the preceding 6 months Any systemic disorders or any medication that affects the periodontal status was excluded from this study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19652040
    Citation
    Buencamino MC, Palomo L, Thacker HL. How menopause affects oral health, and what we can do about it. Cleve Clin J Med. 2009 Aug;76(8):467-75. doi: 10.3949/ccjm.76a.08095.
    Results Reference
    background
    PubMed Identifier
    788632
    Citation
    Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6.
    Results Reference
    background
    PubMed Identifier
    4195183
    Citation
    Aznar Reig A, Zamora Madarias E, Bonilla Mir F, Lopez Campos J, Majua Delgado R. [Hepatic satelite lesion in biliary calculi]. Rev Esp Enferm Apar Dig. 1968 Aug-Sep;27(7):1019-40. No abstract available. Spanish.
    Results Reference
    background
    PubMed Identifier
    3425152
    Citation
    Yobs AR, Plott AE, Hicklin MD, Coleman SA, Johnston WW, Ashton PR, Rube IF, Watts JC, Naib ZM, Wood RJ, et al. Retrospective evaluation of gynecologic cytodiagnosis. II. Interlaboratory reproducibility as shown in rescreening large consecutive samples of reported cases. Acta Cytol. 1987 Nov-Dec;31(6):900-10.
    Results Reference
    result
    PubMed Identifier
    3793432
    Citation
    Tobin JO, Watkins ID, Woodhead S, Mitchell RG. Epidemiological studies using monoclonal antibodies to Legionella pneumophila serogroup 1. Isr J Med Sci. 1986 Oct;22(10):711-4.
    Results Reference
    result

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    Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis

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