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Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VISTA Technique
modified coronally advanced flap
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Age (18-55) Miller's classI and II multiple GR width of KG>2 mm

Exclusion Criteria:

  • Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vista technique

    modified coronally advanced flap

    Arm Description

    The vista technique with PRF membrane uses a Vestibular incision subperiosteal tunnel access in combination with Platelet rich fibrin membrane to treat gingival recession defects.

    A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects.

    Outcomes

    Primary Outcome Measures

    Patient satisfaction
    Using a questionnaire which are designed in a dichotomous fashion (yes or no ) and calculated by percentage of answering yes. it not a scale, the following questions will be asked to the patients; did you feel pain in spite of the medication prescribed? did you perceive the course of healing unexpected restriction? did you experience any remaining symptoms of parasethesia? would you described the under taken effort as reasonable? have your expectations been fulfilled?

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2017
    Last Updated
    January 14, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03328442
    Brief Title
    Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.
    Official Title
    Evaluation of Patient Satisfaction After Root Coverage Procedure Using VISTA Technique Compared to Modified Coronally Advanced Flap Technique in Conjunction With Platelet Rich Fibrin-membrane.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    March 2020 (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
    VISTA technique with PRF compared to MCAF technique with PRF to treat gingival recession
    Detailed Description
    Comparison between two techniques for root coverage divided in two groups the first (test group) VISTA technique in conjunction with PRF-membrane and the second (control group)MCAF technique in conjunction with PRF-membrane for treating Miller's class I and II gingival recession defects. Clinical Periodontal Records will be taken at baseline, 3 months and 6 months respectively. Visual analogue scale for pain during one week after operation. Patient satisfaction record using questionnaire after 6 months.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Vista technique
    Arm Type
    Experimental
    Arm Description
    The vista technique with PRF membrane uses a Vestibular incision subperiosteal tunnel access in combination with Platelet rich fibrin membrane to treat gingival recession defects.
    Arm Title
    modified coronally advanced flap
    Arm Type
    Active Comparator
    Arm Description
    A modified coronally advanced flap utilising Platelet rich fibrin membrane to treat gingival recession defects.
    Intervention Type
    Procedure
    Intervention Name(s)
    VISTA Technique
    Other Intervention Name(s)
    Vestibular incision subperiosteal tunnel access
    Intervention Description
    VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane
    Intervention Type
    Procedure
    Intervention Name(s)
    modified coronally advanced flap
    Other Intervention Name(s)
    MCAF
    Intervention Description
    modified coronally advanced flap with PRF membrane for Treatment of recession class I and II
    Primary Outcome Measure Information:
    Title
    Patient satisfaction
    Description
    Using a questionnaire which are designed in a dichotomous fashion (yes or no ) and calculated by percentage of answering yes. it not a scale, the following questions will be asked to the patients; did you feel pain in spite of the medication prescribed? did you perceive the course of healing unexpected restriction? did you experience any remaining symptoms of parasethesia? would you described the under taken effort as reasonable? have your expectations been fulfilled?
    Time Frame
    after 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Age (18-55) Miller's classI and II multiple GR width of KG>2 mm Exclusion Criteria: Systemic diseases Poor oral hygiene Smoking Patient allergy Miller's class III and IV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed S Saleh, Master
    Phone
    01001628350
    Email
    mssaleh213@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hani M Elnahass, PhD
    Phone
    01000252603
    Email
    Nahass77@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Azza Ezzelarab, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22140667
    Citation
    Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
    Results Reference
    background
    PubMed Identifier
    11022782
    Citation
    Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
    Results Reference
    background
    PubMed Identifier
    24117676
    Citation
    Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
    Results Reference
    background

    Learn more about this trial

    Patient Satisfaction After Root Coverage Using VISTA Technique Compared to MCAF Technique With PRF.

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