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Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VISTA using PRF
VISTA using SCTG
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II
  2. Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972)

Exclusion Criteria:

  1. Any systemic condition that may contraindicate periodontal surgery
  2. Individuals taking medications that interfere with periodontal tissue health or healing
  3. Previous periodontal plastic surgery in the selected sites for at least 6 months before the study
  4. Pregnancy or lactating women
  5. Former or current smokers
  6. Active periodontal disease
  7. Non-compliant patients.
  8. Any restorations found in the selected sites

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VISTA using PRF

    VISTA using SCTG

    Arm Description

    Vestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained

    vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured

    Outcomes

    Primary Outcome Measures

    Amount of root coverage
    complete root coverage after surgical correction measured in millimeters by using periodontal probe

    Secondary Outcome Measures

    Root Coverage Esthetic score a numbering score
    A scoring system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe
    Post-Operative Pain a numerical rating scale
    Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')for the first 2 weeks postoperatively.
    Post-Operative Swelling verbal rating scale
    Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area)
    Post-Surgical Patient Satisfaction numerical rating scale
    A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale.
    Clinical Attachment level gain in millimeters
    the clinical attachment level is the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. measured using a periodontal probe in millimeters.
    Probing depth in millimeters
    It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force.
    Keratinized Tissue Width in millimeters
    It is measured from the free gingival margin to the mucogingival junction (MGJ). By using the periodontal probe, MGJ will be identified using the roll technique
    Gingival Thickness in millimeters
    It is measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove to measure the gingival thickness

    Full Information

    First Posted
    June 25, 2018
    Last Updated
    July 3, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03588052
    Brief Title
    Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions
    Official Title
    Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access Technique in Patients With Multiple Gingival Recessions: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2018 (Anticipated)
    Primary Completion Date
    February 1, 2019 (Anticipated)
    Study Completion Date
    February 20, 2019 (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

    5. Study Description

    Brief Summary
    Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues. Although SCTG is considered a gold standard, it has its own limitations like patient morbidity and graft availability. Consequently, PRF has been introduced in an attempt to overcome the drawbacks of SCTG and achieve optimum results in root coverage. The minimally invasive VISTA technique allows better access with coronal positioning and stabilization of gingival margin to achieve complete root coverage. In addition to platelets-rich fibrin that gives a predictable and reproducible result in restoring the amount of keratinized tissue, root coverage and better esthetic outcome. The use Vestibular incision subperiosteal tunneling access (VISTA) with platelet-rich fibrin will be used to achieve complete root coverage.
    Detailed Description
    Gingival recession is defined as apical displacement of gingival margin beyond the cementoenamel junction leading to the exposure of root surface. There are various etiologic factors for gingival recession like trauma, infection and other anatomical factors. Nowadays, periodontal plastic surgeries for treatment of gingival recession have become an important array due to increase in patient's esthetic demands and other conditions such as dentin hypersensitivity, root caries or abrasion, keratinized tissue augmentation and gingival margin discrepancy. Subepithelial connective tissue grafts (SCTG) are considered the gold standard to obtain maximum root coverage due to its characteristics of quick keratinization and periodontal connective tissue adherence, in addition to its good blood supply to the graft and high degree of gingival color match and esthetics. However, the application of this technique is limited by the thickness of the donor tissue, anatomical factors, limited quantity compromising their use in multiple recession, tissue morbidity, and technique sensitive with postoperative pain, bleeding and swelling. Accordingly, alternative membranes and new biomaterials have been introduced to overcome the limitations of SCTG. Platelet rich fibrin (PRF) was introduced; a second generation platelet concentrate. PRF contains growth factors that play an essential role in soft and hard tissue regeneration; they promote fibroblastic proliferation, increase tissue vascularization, enhance soft tissue healing potential and accelerate bone regeneration. These growth factors include (PDGFs), epidermal growth factor (EGF), transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF). Vestibular incision subperiosteal tunnel access (VISTA), a novel minimal invasive technique for achieving root coverage that overcome the limitation of the previous intrasulcular tunneling techniques. Hence this study will performed to evaluate the use of PRF in conjunction with VISTA technique in management of patients with multiple gingival recessions

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VISTA using PRF
    Arm Type
    Experimental
    Arm Description
    Vestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained
    Arm Title
    VISTA using SCTG
    Arm Type
    Active Comparator
    Arm Description
    vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured
    Intervention Type
    Procedure
    Intervention Name(s)
    VISTA using PRF
    Other Intervention Name(s)
    Vestibular incision subperiosteal tunnel access technique with Platelet-rich fibrin
    Intervention Description
    Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Freshly prepared platelet-rich fibrin will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured
    Intervention Type
    Procedure
    Intervention Name(s)
    VISTA using SCTG
    Other Intervention Name(s)
    Vestibular incision subperiosteal tunnel access technique with Subepithelial connective tissue graft
    Intervention Description
    Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Subepithelial connective tissue graft will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured
    Primary Outcome Measure Information:
    Title
    Amount of root coverage
    Description
    complete root coverage after surgical correction measured in millimeters by using periodontal probe
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Root Coverage Esthetic score a numbering score
    Description
    A scoring system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe
    Time Frame
    6 months
    Title
    Post-Operative Pain a numerical rating scale
    Description
    Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')for the first 2 weeks postoperatively.
    Time Frame
    14 days
    Title
    Post-Operative Swelling verbal rating scale
    Description
    Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area)
    Time Frame
    7 days
    Title
    Post-Surgical Patient Satisfaction numerical rating scale
    Description
    A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale.
    Time Frame
    14 days
    Title
    Clinical Attachment level gain in millimeters
    Description
    the clinical attachment level is the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. measured using a periodontal probe in millimeters.
    Time Frame
    6 months
    Title
    Probing depth in millimeters
    Description
    It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force.
    Time Frame
    6 months
    Title
    Keratinized Tissue Width in millimeters
    Description
    It is measured from the free gingival margin to the mucogingival junction (MGJ). By using the periodontal probe, MGJ will be identified using the roll technique
    Time Frame
    6 months
    Title
    Gingival Thickness in millimeters
    Description
    It is measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove to measure the gingival thickness
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972) Exclusion Criteria: Any systemic condition that may contraindicate periodontal surgery Individuals taking medications that interfere with periodontal tissue health or healing Previous periodontal plastic surgery in the selected sites for at least 6 months before the study Pregnancy or lactating women Former or current smokers Active periodontal disease Non-compliant patients. Any restorations found in the selected sites
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmin Medhat Sery, Bachelor
    Phone
    (+2) 01060122275
    Email
    Yasmin.sery@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed El-Barbary, Phd
    Phone
    01223153678
    Email
    ahmedelbarbary102@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mona Darhous, Phd
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed El-Barbary, Phd
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Marwa Hegab, Phd
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Yasmin Sery, Bachelor
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions

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