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Concentrated Growth Factor in the Treatment of Gingival Recessions

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concentrated Growth Factor Membrane
Coronally Advanced Flap
Sponsored by
Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Multiple gingival recession, Concentrated growth factor, Coronally advanced flap

Eligibility Criteria

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

Inclusion Criteria:

  • systemically and periodontally healthy,
  • non-smokers
  • presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
  • width of keratinized gingiva ≥ 2mm
  • presence of identifiable cemento-enamel junction
  • full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1,
  • presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,

Exclusion Criteria:

  • patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
  • previous surgery in the defects area within the past 1 year,
  • pregnant or lactating females
  • drug and alcohol abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Concentrated growth Factor Membrane

    Coronally Advanced Flap

    Arm Description

    Autogenous platelet and leukocyte fibrin material was obtained from blood.

    Periodontal plastic surgery procedure in the treatment of gingival recession

    Outcomes

    Primary Outcome Measures

    Complete root coverage
    Change from baseline in percentage of complete root coverage at 6th months.

    Secondary Outcome Measures

    Percentage root coverage
    Change from baseline in percentage of root coverage at at 6th months.
    Keratinized gingiva width
    The distance is from the mucogingival junction (MGJ) to the gingival margin
    Recession depth
    The distance is from the cemento-enamel junction to the gingival margin
    Gingival Thickness
    Probing depth
    The distance is from the gingival margin to the bottom of the sulcus
    Clinical attachment loss
    The distance is from the cemento-enamel junction to the bottom of the sulcus.

    Full Information

    First Posted
    March 2, 2015
    Last Updated
    March 5, 2015
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02385734
    Brief Title
    Concentrated Growth Factor in the Treatment of Gingival Recessions
    Official Title
    Concentrated Growth Factor Membrane in the Treatment of Adjacent Multiple Gingival Recessions: A Split Mouth Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study hypothesized that Concentrated Growth Factors'(CGF) placement together with Coronally Advanced Flap (CAF) may enhance the healing of soft tissues. Therefore, the aim of this study was to determine the clinical effect of CGF combination with CAF compared to CAF alone in the treatment of adjacent multiple gingival recessions.
    Detailed Description
    The gingival recessions have been successfully treated by several periodontal plastic surgery procedures. Among the different types of procedures used, Coronally Advanced Flap (CAF) was the most frequent approach, and when combined with a connective tissue graft is accepted as a gold standard therapy. Recently, investigators reported the use of CGF in the reconstruction of bone defects. They concluded that bone formation had significantly increased by using CGF It has been used to accelerate new bone formation associated with guided bone regeneration in sinus augmentation.They stated that CGF may have a better regenerative capacity and high versatility. Therefore, this study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues. Therefore, the aim of this study was to determine the clinical effect of CGF combination with CAF compared to CAF alone in the treatment of adjacent multiple gingival recessions. The patients of this randomized, split mouth and controlled clinical trial study protocol were selected from individuals referred to the Department of Periodontology, at Faculty of Dentistry, Bülent Ecevit University, for either dentin hypersensitivity or aesthetic complaints between April 2013 and April 2014. All the subjects received oral hygiene instructions and full-mouth scaling were performed 1 month before surgery. They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra soft toothbrush. In twenty subjects (mean age 37.10 ±1.03, 20-45years, 13 females, 7 males), one side of the jaw received CAF (control sites)( 59 defects), the opposite site received CAF+CGF (test sites) (60 defects). Full-mouth Plaque index and Gingival index were evaluated before surgery. Custom acrylic guides were fabricated to measure the clinical parameters at the mid-buccal aspect of the treated teeth.Probing depth (PD), Clinical Attachment Loss (CAL),Recession Depth (RD),Keratinized Gingiva Width (KGW) were recorded at the mid-buccal aspect of the treated teeth. Gingival Thickness (GT) was evaluated mid-facially, 2mm apical to the gingival margin at the attached gingiva or the alveolar mucosa, using a 20 endodontic reamer attached to a rubber stopper under the local anesthesia. After carefully removing the reamer, GT was measured with a digital caliper with 0.05 resolution PD, CAL, RD, KGW and GT were assessed at baseline and 6th months. Complete root coverage (CRC)and Percentage Root Coverage(PRC) were calculated at 6th months. Intravenous blood was collected and placed into two different a 10mL glass-coated plastic tube without anticoagulant solutions. These tubes were then immediately centrifuged with a CGF centrifuge machine. The CGF clot was removed from the tube and separated from the Red Blood Cell by using microsurgical scissors. The CGF was squeezed in a special box that produces membranes at a constant thickness of 1mm.CGF membrane was immediately placed over the recession area. All surgeries were performed by the same expert periodontist during a single surgical session Gingival recession sites were randomly determined as either test or control site by tossing a coin immediately before the surgical procedure. Sutures were removed after 10 days and plaque control was maintained by CHX for additional 2 weeks. The patients started brush the tooth at the end of the 3rd week and they were again instructed in mechanical tooth cleaning of the treated tooth using an ultra soft toothbrush and roll technique. Oral hygiene instructions were provided at each postoperative visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    Multiple gingival recession, Concentrated growth factor, Coronally advanced flap

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Concentrated growth Factor Membrane
    Arm Type
    Experimental
    Arm Description
    Autogenous platelet and leukocyte fibrin material was obtained from blood.
    Arm Title
    Coronally Advanced Flap
    Arm Type
    Active Comparator
    Arm Description
    Periodontal plastic surgery procedure in the treatment of gingival recession
    Intervention Type
    Other
    Intervention Name(s)
    Concentrated Growth Factor Membrane
    Other Intervention Name(s)
    An agent of platelet concentrates
    Intervention Description
    Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronally Advanced Flap
    Intervention Description
    Periodontal plastic surgery technique
    Primary Outcome Measure Information:
    Title
    Complete root coverage
    Description
    Change from baseline in percentage of complete root coverage at 6th months.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Percentage root coverage
    Description
    Change from baseline in percentage of root coverage at at 6th months.
    Time Frame
    6 months
    Title
    Keratinized gingiva width
    Description
    The distance is from the mucogingival junction (MGJ) to the gingival margin
    Time Frame
    6 months
    Title
    Recession depth
    Description
    The distance is from the cemento-enamel junction to the gingival margin
    Time Frame
    6 th months
    Title
    Gingival Thickness
    Time Frame
    6 months
    Title
    Probing depth
    Description
    The distance is from the gingival margin to the bottom of the sulcus
    Time Frame
    6 months
    Title
    Clinical attachment loss
    Description
    The distance is from the cemento-enamel junction to the bottom of the sulcus.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemically and periodontally healthy, non-smokers presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch width of keratinized gingiva ≥ 2mm presence of identifiable cemento-enamel junction full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1, presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area, Exclusion Criteria: patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion, previous surgery in the defects area within the past 1 year, pregnant or lactating females drug and alcohol abuse

    12. IPD Sharing Statement

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    Concentrated Growth Factor in the Treatment of Gingival Recessions

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