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Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects

Primary Purpose

Periodontal Diseases, Bone Resorption

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Platelet rich fibrin
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 Diseases focused on measuring Periodontal disease, Platelet rich fibrin

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects.

Exclusion Criteria:

  • Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Platelet rich Fibrin

    Bioactive glass

    Arm Description

    The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.

    The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone

    Outcomes

    Primary Outcome Measures

    Intrabony defect fill
    change in intrabony defect fill from baseline to 9 months

    Secondary Outcome Measures

    Probing depth
    change in probing depth from baseline to 9 months
    Clinical attachment level
    change in Clinical attachment level from baseline to 9 months
    Gingival Index
    change in Gingival Index from baseline to 9 months

    Full Information

    First Posted
    December 1, 2016
    Last Updated
    December 1, 2016
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
    Collaborators
    Santosh University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02982681
    Brief Title
    Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects
    Official Title
    COMPARATIVE EVALUATION OF BIOACTIVE GLASS PUTTY AND PLATELET RICH FIBRIN IN THE TREATMENT OF HUMAN PERIODONTAL INTRABONY DEFECTS- A CLINICAL AND RADIOGRAPHICAL STUDY"
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be effective in promoting reduction in probing depth, gain in clinical attachment, and defect fill in intrabony periodontal defects. The individual role played by bioactive glass putty in combination with PRF is yet to be elucidated. AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects in humans. Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on other side. The primary outcomes of the study included changes in probing depth, attachment level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3, 6, and 9 months. Radiographic assessment was done using standardized intra oral periapical radiographs. Comparisions were made within each group between baseline, 3 months, 6 months and 9 months using the ANOVA test followed by Bonferroni test.
    Detailed Description
    INTRODUCTION Periodontitis is an infectious disease that causes destruction of the attachment apparatus.[1].The mainstay aim of periodontal treatment is the regeneration of the lost attachment apparatus of the teeth. Variety of treatment modalities are available for periodontal regenerative therapy including bone grafts, bone substitutes, Guided Tissue Regeneration, growth factors, application of tissue engineering or the combination of two or more of the above listed approaches. [2] Alloplasts, may be an effective alternative to allograft and xenografts as there is no risk of disease transmission and the supply is unlimited.[3] The Bioactive glass promotes osteogenesis by adsorption and concentrations of protein utilized by osteoblast to form a mineralized extracellular matrix. [4] The advantage of the putty form of bioactive glass is the glycerine and polyethylene glycol which makes the glass particle coherent and thus enhancing handling characteristics and minimal migration of graft particles from the defect site. [5] Histological evaluation of material has shown that the particulate tends to retard the down growth of epithelial tissue. [6,7,8,9] Growth factors play a pivotal role in periodontal regeneration. Platelet Rich Fibrin is believed to release polypeptide growth factors, such as transforming growth factors-ß, platelet derived growth factors, vascular endothelial growth factors and matrix glycoproteins (such as thrombospondin -1) into the surgical wound in a sustained fashion for at least 7 days as shown in vitro. [10] Thus, given the unique graft with osteoconductive, osteoinductive and osteostimulative properties and properties of autologous PRF, application of combination approach was attempted for the assessment of their additional benefits to the healing mechanisms and periodontal regeneration in intrabony defects. Materials and methods Patient Selection This randomized control trial was carried out in the Department of Periodontics and Oral Implantology, Santosh Dental College and Hospital, Santosh University, Ghaziabad. Ten patients suffering chronic localized periodontitis aged between 20 -50 years (7 males and 3 females) with 10 pairs of contalateral intraosseous defects (n=20) comprised the study population. A total of 20 bone defects (10 pairs) were decided by the statisticion to be of statistical strength. Convenient sampling design was used for the enrolment of study patients. Ethical approval was taken from the institutional ethical committee The patients were explained in detail about the procedure and a written informed consent was taken. The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects. [3] Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study. PRESURGICAL THERAPY Patients underwent phase I therapy. The selected defects were evaluated after 2 weeks, and persistent pockets > or = 5mm and patients with clinical radiographic evidence of angular osseous defects were scheduled for surgery. Clinical Parameters : Oral hygiene status was recorded using the gingival index of Loe & Sillness,[11]; with score 0 indicating absence of inflammation and score 3 indicating severe inflammation and plaque index of Silness & Loe. [12] Probing pocket depth and Clinical attachment level were recorded at baseline on the day of surgery, 3, 6 and 9 months intervals using UNC-15 probe and customized acrylic occlusal stents grooved in the area of defect to provide reproducible insertion axis- The following measurements were recorded with customized acrylic stent: Fixed reference point (FRP) to the base of pocket (BP) Fixed reference point (FRP) to the cemento-enamel junction (CEJ) Fixed reference point (FRP) to the gingival margin (GM) PPD and CAL were calculated from these probing measurements as: PPD = (FRP to BP) - (FRP to GM) CAL= (FRP to BP) - (FRP to CEJ) Radiographic measurements: Standardized intra-oral periapical radiographs of the defects were taken using a paralleling technique.[13] Amount of defect fill: Defects were measured from the fixed reference point (distance between the cemento-enamel junction to the radiographic base of the bone defect ) with the help of 1.1 mm grid and the following radiographic features were recorded on the day of surgery, 3, 6 and 9 months intervals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Bone Resorption
    Keywords
    Periodontal disease, Platelet rich fibrin

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet rich Fibrin
    Arm Type
    Experimental
    Arm Description
    The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.
    Arm Title
    Bioactive glass
    Arm Type
    Active Comparator
    Arm Description
    The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone
    Intervention Type
    Drug
    Intervention Name(s)
    Platelet rich fibrin
    Other Intervention Name(s)
    PRF
    Intervention Description
    In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site
    Intervention Type
    Drug
    Intervention Name(s)
    Bioactive Glass
    Other Intervention Name(s)
    Novabone
    Intervention Description
    The control site were packed with the bioactive glass graft alone
    Primary Outcome Measure Information:
    Title
    Intrabony defect fill
    Description
    change in intrabony defect fill from baseline to 9 months
    Time Frame
    baseline to 9 months
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    change in probing depth from baseline to 9 months
    Time Frame
    baseline to 9 months
    Title
    Clinical attachment level
    Description
    change in Clinical attachment level from baseline to 9 months
    Time Frame
    baseline to 9 months
    Title
    Gingival Index
    Description
    change in Gingival Index from baseline to 9 months
    Time Frame
    baseline to 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The intrabony defects were diagnosed clinically with moderate to deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of vertical/angular osseous defects. Exclusion Criteria: Patients with systemic diseases, on anticoagulants, those with habit of smoking and alcohol, with known history of allergy to graft material and who have undergone periodontal surgical treatment for chronic periodontitis within twelve months for the same defects were excluded from the study.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10368057
    Citation
    Hall EE, Meffert RM, Hermann JS, Mellonig JT, Cochran DL. Comparison of bioactive glass to demineralized freeze-dried bone allograft in the treatment of intrabony defects around implants in the canine mandible. J Periodontol. 1999 May;70(5):526-35. doi: 10.1902/jop.1999.70.5.526.
    Results Reference
    background
    PubMed Identifier
    19089687
    Citation
    Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
    Results Reference
    background

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    Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects

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