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Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients

Primary Purpose

Periodontitis Chronic Generalized Severe, Intrabony Periodontal Defect

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-Incised Papilla Surgical Approach
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis Chronic Generalized Severe focused on measuring minimal invasive technique, NIPSA, Allograft, PRF

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with Stage III periodontitis patient having at least one tooth with two wall or combined two to three walled intraosseous defect more than or equal 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal 6 mm.
  • Defect not extending to a root furcation area.
  • Vital teeth
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • No surgical periodontal therapy carried out in the past 6 months.
  • Able to sign an informed consent form.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Able to come for the follow up appointment's needed.

Exclusion Criteria:

  • Any systemic disease that contra-indicates periodontal surgery or may affect healing.
  • Smokers
  • Pregnant females
  • Drug abusers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    NIPSA technique with Allograft plus PRF

    NIPSA technique

    Arm Description

    Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF

    Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF

    Outcomes

    Primary Outcome Measures

    Clinical attachment level gain (CAL) clinical attachment level gain (CAL)
    measured with UNC periodontal probe in mm

    Secondary Outcome Measures

    Gingival recession (GR)
    measured with UNC periodontal probe in mm
    Pocket depth (PD)
    measured with UNC periodontal probe in mm
    Radiographic defect fill
    standardized digital periapical radiograph
    Gingival bleeding
    Gingival bleeding score
    Plaque index
    Plaque Index score
    Post-surgical patient Satisfaction
    (1-7) point scale

    Full Information

    First Posted
    June 19, 2020
    Last Updated
    June 22, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04444063
    Brief Title
    Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients
    Official Title
    Clinical and Radiographic Evaluation of the Non-Incised Papilla Surgical Approach With and Without Allograft Plus Platelet Rich Fibrin in Treatment of Intraosseous Defects in Stage III Periodontitis Patients: A Randomized-Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Several minimal invasive techniques have been proposed since the last decade aiming to enhance and provide adequate environment for periodontal regeneration. Harrel and Rees proposed minimally invasive surgery (MIS) in 1995 and minimal invasive surgical technique (MIST) that was introduced in 2007 and then further enforced with modified minimally invasive surgical technique (M-MIST) in 2009 . A new minimal invasive technique called Non-Incised Papilla Surgical Approach (NIPSA) was introduced in 2017. It is aims to maintain the marginal tissues integrity by placing horizontal or oblique incision apical to the defect approaching the defect through apical access.
    Detailed Description
    Intraosseous vertical defects are one of the consequences that could result from periodontitis, which are classified according to their architecture by the number of residual walls, defect width as well as topographic extension in relation to the tooth. Conventional surgery done for regenerative purpose regarding vertical defects has been known to be affected by clot stability, it was reported in the literature that reduced clinical outcomes occurred when early wound failure and exposure of the treated area occurred. This led to the innovation of different minimally invasive flap techniques that aimed at reducing the surgical trauma, allowing blood clot stability, protecting the regenerating site, reducing patient discomfort postoperatively as well as minimizing surgical chair time Among these techniques are papilla preservation flaps and minimally invasive surgical approaches with papilla elevation or without papilla elevation . However, these techniques had in their design incisions related to the interdental papilla which would jeopardize and complicate the vascular integrity of the interdental tissues Non incised Papilla surgical approach is a new surgical technique introduced by Moreno Rodriguez in 2017 to maintain the marginal tissues and the papilla intact by placing a horizontal or oblique incision apical to the defect and approaching it through an apical access leaving the marginal tissues to act as a "dome " protecting the blood clot

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis Chronic Generalized Severe, Intrabony Periodontal Defect
    Keywords
    minimal invasive technique, NIPSA, Allograft, PRF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    it is a Randomized clinical trial
    Masking
    Outcomes Assessor
    Masking Description
    single blinded
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NIPSA technique with Allograft plus PRF
    Arm Type
    Experimental
    Arm Description
    Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF
    Arm Title
    NIPSA technique
    Arm Type
    Active Comparator
    Arm Description
    Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-Incised Papilla Surgical Approach
    Intervention Description
    Horizontal or oblique incision is done on the buccal mucosa as far as possible from the marginal keratinized tissue and the inter dental papilla The horizontal/oblique incision is extended mesio-distally enough to allow proper visualization of the defect A full thickness flap is elevated apico- coronally to expose the coronal limit of the defect Scaling and root planning are done using mini-curettes and power driven ultrasonic tips with care trying to maintain fibers attached to the cementum Granulation tissue is removed with mini-curettes detached from the bony walls and removed from the base of the papilla carefully with microblades and microscissors . 1ry soft tissue closure will be performed by horizontal mattress suture 2mm from the edges of the incision as a first line of closure and then simple interrupted suture as a second line of closure using (5-0, 6-0) polypropylene suture.
    Primary Outcome Measure Information:
    Title
    Clinical attachment level gain (CAL) clinical attachment level gain (CAL)
    Description
    measured with UNC periodontal probe in mm
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Gingival recession (GR)
    Description
    measured with UNC periodontal probe in mm
    Time Frame
    12 months
    Title
    Pocket depth (PD)
    Description
    measured with UNC periodontal probe in mm
    Time Frame
    12 months
    Title
    Radiographic defect fill
    Description
    standardized digital periapical radiograph
    Time Frame
    12 months
    Title
    Gingival bleeding
    Description
    Gingival bleeding score
    Time Frame
    T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical
    Title
    Plaque index
    Description
    Plaque Index score
    Time Frame
    12 months
    Title
    Post-surgical patient Satisfaction
    Description
    (1-7) point scale
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with Stage III periodontitis patient having at least one tooth with two wall or combined two to three walled intraosseous defect more than or equal 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal 6 mm. Defect not extending to a root furcation area. Vital teeth No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. No surgical periodontal therapy carried out in the past 6 months. Able to sign an informed consent form. Patients who are cooperative, motivated, and hygiene conscious. Able to come for the follow up appointment's needed. Exclusion Criteria: Any systemic disease that contra-indicates periodontal surgery or may affect healing. Smokers Pregnant females Drug abusers
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed M. Elkady, MSc
    Phone
    01005641154
    Ext
    002
    Email
    ahmedelkady442@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Omneya Abo-Eldahab, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Omneya K. Tawfeek, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    I will check with my study chairs
    Citations:
    PubMed Identifier
    31190409
    Citation
    Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
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    Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients

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