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Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Porous variant of Bioactive Glass.
Non porous variant of Bioactive Glass.
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • INCLUSION CRITERIA

    1. Age: 18-55 years.
    2. Probing Depth >5mm.

Exclusion Criteria:

  • EXCLUSION CRITERIA

    1. History of periodontal treatment last six months.
    2. Bleeding disorders.
    3. Gross oral pathology.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    porous bone graft group

    Non-porous bone gaft group

    Arm Description

    Intervention: Flap surgery procedure with porous bone grafting (Periooglass)

    Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels)

    Outcomes

    Primary Outcome Measures

    Change in relative attachment loss

    Secondary Outcome Measures

    Change in probing depth
    Change in plaque index

    Full Information

    First Posted
    May 29, 2015
    Last Updated
    June 2, 2015
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02463006
    Brief Title
    Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects
    Official Title
    Comparative Evaluation of Porous and Non Porous Variants of Bioactive Glass in the Treatment of Periodontal Intrabony Defects: A Cone Beam Computed Tomography Analysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. D. Y. Patil Dental College & Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Till date, no study has been reported in the literature where porous bioactive glass was used for the management of periodontal osseous defects. In this context, the present study is designed to assess the efficacy of the porous variant of bioactive glass and compare with that of nonporous variant using cone beam computed tomography.
    Detailed Description
    OBJECTIVES: To evaluate clinically the periodontal healing with Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months. To evaluate clinically the periodontal healing with Non Porous variant of Bioactive Glass placed in the intra bony defects at an interval of 6 months. To evaluate the radiographic changes in the intra bony defect grafted with Porous variant of Bioactive Glass at baseline and an interval of 6 months. To evaluate the radiographic changes in the intra bony defect grafted with Non Porous variant of Bioactive Glass at baseline and an interval of 6 months. To compare clinically soft tissue healing for sites grafted with Porous variant of Bioactive Glass and sites grafted with Non Porous variant of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months. To compare the radiographic changes for sites grafted with Porous variant and sites grafted with Non Porous of Bioactive Glass in the treatment of periodontal intra bony defects at an interval of 6 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    porous bone graft group
    Arm Type
    Experimental
    Arm Description
    Intervention: Flap surgery procedure with porous bone grafting (Periooglass)
    Arm Title
    Non-porous bone gaft group
    Arm Type
    Active Comparator
    Arm Description
    Intervention: Flap surgery procedure with non-porous bone grafting (Novabone morsels)
    Intervention Type
    Drug
    Intervention Name(s)
    Porous variant of Bioactive Glass.
    Intervention Description
    Flap surgery with Porous variant of Bioactive Glass.
    Intervention Type
    Drug
    Intervention Name(s)
    Non porous variant of Bioactive Glass.
    Intervention Description
    Flap surgery with non-Porous variant of Bioactive Glass.
    Primary Outcome Measure Information:
    Title
    Change in relative attachment loss
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in probing depth
    Time Frame
    6 months
    Title
    Change in plaque index
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: INCLUSION CRITERIA Age: 18-55 years. Probing Depth >5mm. Exclusion Criteria: EXCLUSION CRITERIA History of periodontal treatment last six months. Bleeding disorders. Gross oral pathology.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23055593
    Citation
    Gokhale ST, Dwarakanath CD. The use of a natural osteoconductive porous bone mineral (Bio-Oss) in infrabony periodontal defects. J Indian Soc Periodontol. 2012 Apr;16(2):247-52. doi: 10.4103/0972-124X.99270.
    Results Reference
    result
    PubMed Identifier
    21692628
    Citation
    Wohlfahrt JC, Aass AM, Ronold HJ, Heijl L, Haugen HJ, Lyngstadaas SP. Microcomputed tomographic and histologic analysis of animal experimental degree II furcation defects treated with porous titanium granules or deproteinized bovine bone. J Periodontol. 2012 Feb;83(2):211-21. doi: 10.1902/jop.2011.110128. Epub 2011 Jun 21.
    Results Reference
    result

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    Porous and Non-porous Bone Grafts in Intra-bony Periodontal Defects

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