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Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects

Primary Purpose

Periodontal Bone Loss, Periodontal Pocket

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
locally injected vitamin D
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Bone Loss

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with infrabony vertical defects
  • systemically free patients
  • periodontally affected patients

Exclusion Criteria:

  • patients with systemic diseases
  • smokers
  • pregnency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    non-surgical periodontal regeneration

    surgical peridoontal regeneration

    Arm Description

    non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect

    surgical periodontal regeneration using bone graft and collagen barrier

    Outcomes

    Primary Outcome Measures

    radiographic interproximal bone level
    radiographic interproximal bone level

    Secondary Outcome Measures

    Full Information

    First Posted
    October 13, 2018
    Last Updated
    October 22, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03716765
    Brief Title
    Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects
    Official Title
    Locally Injected Vitamin D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects: Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    vitamin D has great role in bone regenration and soft tissue health. in the past periodontal regeneration was performed using bone graft and barrier membrane
    Detailed Description
    there was no previous studies used the locally injected vitamin d in periodontal regeneration. therefore, we intended to study the effect of locally injected vitamin D in peridoontal regerneration in comparison with the conventional surgical technique

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Bone Loss, Periodontal Pocket

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    non-surgical periodontal regeneration
    Arm Type
    Experimental
    Arm Description
    non-surgical periodontal regeneration using locally injected vitamin d to treat the infrabony defect
    Arm Title
    surgical peridoontal regeneration
    Arm Type
    Active Comparator
    Arm Description
    surgical periodontal regeneration using bone graft and collagen barrier
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    locally injected vitamin D
    Other Intervention Name(s)
    non-surgical periodontal rgeneration
    Intervention Description
    locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects
    Primary Outcome Measure Information:
    Title
    radiographic interproximal bone level
    Description
    radiographic interproximal bone level
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with infrabony vertical defects systemically free patients periodontally affected patients Exclusion Criteria: patients with systemic diseases smokers pregnency
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    nermin yussif
    Organizational Affiliation
    october university of modern sciences and arts
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Locally Injected Vit D as a Non-surgical Modality for Periodontal Regeneration of Infrabony Defects

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