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Gingival Recession Treatment With Concentrated Growth Factor(CGF)

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
test groups
control groups
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring growth factor, mucogingival surgery, gingival recession

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age≥18
  • systemically and periodontally healthy non-smoker patients
  • multiple, adjacent, bilaterally Miller class I
  • recession depth ≥2 and ≤5 mm, probing depth≤3 mm, located lateral, canine or premolars on same arch(maxilla or mandibula)
  • identifiable cemento-enamel junction
  • absence caries or restoration on buccal surface, endodontic treatment or problem
  • palatal donor tissue thickness ≥3 mm for SCTG

Exclusion Criteria:

  • patients have smoking habit or systemic diseases that might be contraindication for periodontal surgery
  • the presence of using medication affect that blood clotting mechanism and wound healing
  • previous periodontal surgeries in gingival recession areas
  • pregnancy, lactation,or oral contraceptive drug intake for female patients
  • insufficient oral hygiene (full- mouth plaque and bleeding scores ≥15% after phase I periodontal treatment)
  • unchanged traumatic tooth-brushing habit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    test groups

    control groups

    Arm Description

    In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups.In test groups, a special centrifuge machine(Medifuge) and subjects venous blood were used to obtain Concentrated growth factor. A special compress was used to transform Concentrated growth factor membrane.

    In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups. In control groups, subepithelial connective tissue graft was taken from the palatal canine teeth-first molar teeth area with a trap door technique according to the width of the exposed root surface and the adjacent bone margins. The graft's thickness was adjusted between 1.5 and 2 mm.

    Outcomes

    Primary Outcome Measures

    recession depth
    recession depth was measured distance from cemento-enamel junction(CEJ) to the gingival margin, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
    root coverage
    Root coverage(RC) was calculated for multiple recession defects groups with a formula.
    keratinized tissue thickness
    Keratinized tissue thickness(KTT) value was obtained from a digital caliper with the accuracy of 0.01 mm and using a 15 endodontic reamer, on mid-point localization of keratinized tissue or the alveolar mucosa, at level bottom of the gingival crevice.
    keratinized tissue weight
    keratinized tissue weight was measured distance from the free gingival margin to the mucogingival junction, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
    clinical attachment level
    clinical attachment level was mesured distance from CEJ to the bottom of the gingival crevice

    Secondary Outcome Measures

    wound healing
    Wound healing was evaluated with healing index.
    VAS scores for pain evaluation
    Visual analog scale(VAS) with 100 mm was used in patient postoperative pain level for first seven days.No pain level was indicated as 0, and unbearable pain level on the VAS was also indicates as 100.

    Full Information

    First Posted
    December 30, 2016
    Last Updated
    February 7, 2019
    Sponsor
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03020732
    Brief Title
    Gingival Recession Treatment With Concentrated Growth Factor(CGF)
    Official Title
    Concentrated Growth Factor Membrane Versus Subepithelial Connective Tissue Grafts in Treatment of Multiple Gingival Recession Defects: a Split-mouth Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Platelet concentrates(PC) are used in the field of periodontology and implantology for the content necessary key cells and growth factors to accelerate healing and to provide regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and subepithelial connective tissue graft(SCTG) with CAF in the treatment of Miller class I gingival recessions (GR).
    Detailed Description
    CGF is defined as an innovative method to produce platelet rich fibrin(PRF) or a new generation platelet concentrate(PC).The rotational speed of the centrifuge machine used in CGF, varies between 2400-3000 rpm. The variability of the rotation speed during centrifugation allows a fibrin matrix that larger, more intensive and includes more growth factors than PRF. Some studies have been reported that CGF have an inducing effect on periodontal ligament stem cells for osteogenic differentiation and clinically provides new bone formation for the sinus augmentation. In literature, there is only one clinical research associated with multiple gingival recession defects treatment. It showed that CGF with CAF surgery increases keratinized gingiva weight and thickness and it maybe prevents post-operative relapse for CAF. PC has also been mentioned to be effective in to increase the width of keratinized tissue with providing root coverage and it may reduce early post-surgical complications, and accelerate wound healing in systematic review. In the treatment of isolated or multiple gingival recession, PRF and SCTG with CAF procedures have been reported to similar root coverage. PRF can be used as an alternative method for SCTG .CGF and PRF have similar composition. However higher resistance and viscosity of CGF may protect growth factors from proteolysis better than PRF. There is any comparative study for CGF and SCTG in literature in terms of clinically or patient related parameters. Therefore, the purpose of this clinical study is to evaluate the clinical efficacy of CGF in combination with CAF in the treatment of gingival recession's defects, and to compare SCTG in combination with CAF. It is also aimed to asses and compare postoperative pain and soft tissue healing.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    growth factor, mucogingival surgery, gingival recession

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    test groups
    Arm Type
    Experimental
    Arm Description
    In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups.In test groups, a special centrifuge machine(Medifuge) and subjects venous blood were used to obtain Concentrated growth factor. A special compress was used to transform Concentrated growth factor membrane.
    Arm Title
    control groups
    Arm Type
    Active Comparator
    Arm Description
    In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups. In control groups, subepithelial connective tissue graft was taken from the palatal canine teeth-first molar teeth area with a trap door technique according to the width of the exposed root surface and the adjacent bone margins. The graft's thickness was adjusted between 1.5 and 2 mm.
    Intervention Type
    Procedure
    Intervention Name(s)
    test groups
    Other Intervention Name(s)
    CGF+ CAF groups
    Intervention Description
    Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Concentrated growth factor(CGF) membranes were placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
    Intervention Type
    Procedure
    Intervention Name(s)
    control groups
    Other Intervention Name(s)
    SCTG+CAF
    Intervention Description
    Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Subepithelial connective tissue graft was placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
    Primary Outcome Measure Information:
    Title
    recession depth
    Description
    recession depth was measured distance from cemento-enamel junction(CEJ) to the gingival margin, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    root coverage
    Description
    Root coverage(RC) was calculated for multiple recession defects groups with a formula.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    keratinized tissue thickness
    Description
    Keratinized tissue thickness(KTT) value was obtained from a digital caliper with the accuracy of 0.01 mm and using a 15 endodontic reamer, on mid-point localization of keratinized tissue or the alveolar mucosa, at level bottom of the gingival crevice.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    keratinized tissue weight
    Description
    keratinized tissue weight was measured distance from the free gingival margin to the mucogingival junction, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    clinical attachment level
    Description
    clinical attachment level was mesured distance from CEJ to the bottom of the gingival crevice
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Secondary Outcome Measure Information:
    Title
    wound healing
    Description
    Wound healing was evaluated with healing index.
    Time Frame
    after surgery first, second and third week
    Title
    VAS scores for pain evaluation
    Description
    Visual analog scale(VAS) with 100 mm was used in patient postoperative pain level for first seven days.No pain level was indicated as 0, and unbearable pain level on the VAS was also indicates as 100.
    Time Frame
    after surgery first seven days
    Other Pre-specified Outcome Measures:
    Title
    Plaque index
    Description
    plaque index (Silness &Löe index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    Gingival index
    Description
    Gingival index(Löe &Silness index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively
    Title
    Probing pocket depth
    Description
    Probing pocket depth was measured distance from the gingival margin to the bottom of the gingival crevice.
    Time Frame
    change from baseline at following surgery first, third and sixth month respectively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age≥18 systemically and periodontally healthy non-smoker patients multiple, adjacent, bilaterally Miller class I recession depth ≥2 and ≤5 mm, probing depth≤3 mm, located lateral, canine or premolars on same arch(maxilla or mandibula) identifiable cemento-enamel junction absence caries or restoration on buccal surface, endodontic treatment or problem palatal donor tissue thickness ≥3 mm for SCTG Exclusion Criteria: patients have smoking habit or systemic diseases that might be contraindication for periodontal surgery the presence of using medication affect that blood clotting mechanism and wound healing previous periodontal surgeries in gingival recession areas pregnancy, lactation,or oral contraceptive drug intake for female patients insufficient oral hygiene (full- mouth plaque and bleeding scores ≥15% after phase I periodontal treatment) unchanged traumatic tooth-brushing habit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma Berrin Ünsal
    Organizational Affiliation
    affiliated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    there is no plan to make IPD. IPD will be formed if necessary.
    Citations:
    PubMed Identifier
    26269089
    Citation
    Bozkurt Dogan S, Ongoz Dede F, Balli U, Atalay EN, Durmuslar MC. Concentrated growth factor in the treatment of adjacent multiple gingival recessions: a split-mouth randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):868-875. doi: 10.1111/jcpe.12444. Epub 2015 Sep 22.
    Results Reference
    result
    PubMed Identifier
    25734713
    Citation
    Tunaliota M, Ozdemir H, Arabaciota T, Gurbuzer B, Pikdoken L, Firatli E. Clinical evaluation of autologous platelet-rich fibrin in the treatment of multiple adjacent gingival recession defects: a 12-month study. Int J Periodontics Restorative Dent. 2015 Jan-Feb;35(1):105-14. doi: 10.11607/prd.1826.
    Results Reference
    result
    PubMed Identifier
    24362634
    Citation
    Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.
    Results Reference
    result
    PubMed Identifier
    22292152
    Citation
    Jankovic S, Aleksic Z, Klokkevold P, Lekovic V, Dimitrijevic B, Kenney EB, Camargo P. Use of platelet-rich fibrin membrane following treatment of gingival recession: a randomized clinical trial. Int J Periodontics Restorative Dent. 2012 Apr;32(2):e41-50.
    Results Reference
    result
    PubMed Identifier
    20820456
    Citation
    Jankovic S, Aleksic Z, Milinkovic I, Dimitrijevic B. The coronally advanced flap in combination with platelet-rich fibrin (PRF) and enamel matrix derivative in the treatment of gingival recession: a comparative study. Eur J Esthet Dent. 2010 Autumn;5(3):260-73.
    Results Reference
    result
    PubMed Identifier
    19186964
    Citation
    Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
    Results Reference
    result
    PubMed Identifier
    19905939
    Citation
    Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.
    Results Reference
    result

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    Gingival Recession Treatment With Concentrated Growth Factor(CGF)

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