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Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession

Primary Purpose

RT2 Gingival Recession

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RT2 Gingival Recession focused on measuring tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue graft,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site

Exclusion Criteria:

Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Overlapping teeth or teeth with abnormal alignment in the dental arch.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    deepithelializ free gingival graft

    subepithelial connective tissue graft

    Arm Description

    performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession

    performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession

    Outcomes

    Primary Outcome Measures

    the distance between the contact point and the top of the papilla
    measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    September 24, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04104087
    Brief Title
    Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession
    Official Title
    The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 10, 2019 (Anticipated)
    Primary Completion Date
    July 10, 2020 (Anticipated)
    Study Completion Date
    April 10, 2021 (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
    Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures. According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.
    Detailed Description
    Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects. Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects. However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course. To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    RT2 Gingival Recession
    Keywords
    tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue graft,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    it is randomized control trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    double
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    deepithelializ free gingival graft
    Arm Type
    Experimental
    Arm Description
    performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession
    Arm Title
    subepithelial connective tissue graft
    Arm Type
    Active Comparator
    Arm Description
    performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession
    Intervention Type
    Procedure
    Intervention Name(s)
    tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
    Other Intervention Name(s)
    root coverage
    Intervention Description
    enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
    Primary Outcome Measure Information:
    Title
    the distance between the contact point and the top of the papilla
    Description
    measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    the minimum age should be 18 years
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site Exclusion Criteria: Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits. Overlapping teeth or teeth with abnormal alignment in the dental arch.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    sarah Elshourbagy, MSC
    Phone
    01288624000
    Email
    sara_elshourbagy@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Manal Hosny, phd
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Hani ElNahass, 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 chair
    Citations:
    PubMed Identifier
    19968743
    Citation
    Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.
    Results Reference
    result

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    Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession

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