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Growth Factors in the Localized Gingival Recessions Treatment

Primary Purpose

Localized Gingival Recession

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

About this trial

This is an interventional treatment trial for Localized Gingival Recession focused on measuring localized gingival recession, Platelet rich fibrin, concentrated growth factor, coronally advanced flap

Eligibility Criteria

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

Inclusion Criteria:

  • systemically and periodontally healthy,
  • non-smokers
  • presence of 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

    Platelet Rich Fibrin

    Arm Description

    Autogenous platelet and leukocyte fibrin material was obtained from blood.

    Autogenous platelet and leukocyte fibrin material was obtained from blood.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Percentage of mean root coverage
    Change from baseline in percentage ofmean root coverage at 6th months.
    Keratinized gingiva width
    The distance is from the cemento-enamel junction to the gingival margin
    Recession depth
    The distance is from the cemento-enamel junction to the gingival margin

    Full Information

    First Posted
    December 25, 2021
    Last Updated
    December 25, 2021
    Sponsor
    Bulent Ecevit University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05188768
    Brief Title
    Growth Factors in the Localized Gingival Recessions Treatment
    Official Title
    Clinical Effects of Concentrated Growth Factor and Platelet-Rich Fibrin in the Treatment of Localized Gingival Recessions: A Split-Mouth Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    November 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the clinical efficacy of concentrated-growth-factor (CGF) in combination with coronally-advanced-flap (CAF) compared with platelet-rich-fibrin (PRF)+CAF for the treatment of localized gingival-recessions (GRs)
    Detailed Description
    Gingival recession (GR) is a common mucogingival deformity. The root surface (RS) exposed by GR is treated with various surgical techniques.Traditionally, if GT and height of the keratinized gingiva (KG) are sufficient, the coronally advanced flap (CAF) technique is commonly used to close the exposed RS.Platelets contain various growth factors (GFs) to initiate healing process or regeneration of tissue.The second generation of platelet concentrates is platelet-rich fibrin (PRF) that are obtained from the centrifugation of blood (2700/3000rpm for 12 min) without anticoagulant or bovine trombin.And, the third generation of platelets concentrates is concentrated growth factor (CGF) as a new approach to produce PRF.It stated that the modified speed during centrifugation contribute the dense fibrin matrix in which includes larger, more intensive, more GFs than PRF.CGF is considered to be a biomaterial that is better than PRF in bone regeneration, but there is no study compare the clinical effects of CGF and PRF in the treatment of localized GRs. Our study hypothesized that if CGF has better regenerative capacity than PRF, the use of CGF in the treatment of GRs as a natural biomaterial may enhace the percentage of RC or healing of soft tissue compared with PRF. Therefore, the purpose of this study was to compare clinical effects of CGF and PRF in the treatment of localized GRs. The patients of this randomized, split-mouth and controlled clinical trial study protocol were selected from individuals referred to the Department of Periodontology, at the Faculty of Dentistry, Bulent Ecevit University, for either dentin hypersensitivity or aesthetic complaints between April 2015 and June 2017. The subjects were enrolled to this study based on the following inclusion criteria: (1) age > 18 years, (2) systemically and periodontally healthy, (3) non-smokers, (4) presence of ≥2 buccal adjacent Miller Class I or II GR with ≥2 mm GR depth (RD), probing depth (PD) <3 mm and gingival thickness (GT) ≥1 mm on both sides of the maxillary arch, (5) width of keratinized gingiva (KGW) ≥2 mm, (6) presence of identifiable cemento-enamel junction CEJ, (7) central, lateral canine and premolar teeth with GRs in the maxilla (8) full-mouth plaque control record (PCR) ≤20% (O'Leary et al. 1972) and gingival index (GI) scores = 0 (Loe, 1967) and presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area. 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 eighteen patients (mean age 39.67₊10.25 age; 8 females, 10 males), one side of the jaw received PRF+ CAF (37 defects), the opposite site received CGF + CAF (39 defects). Application of PRF membrane to the control region: The patient's venous blood was taken into the 10-ml test tubes and placed quickly in the Electro-Mag centrifuge (M 815 P, İstanbul, Turkey) without shaking. The device was operated at 2700 rpm for 12 minutes to obtain PRF. Application of CGF membrane to the test region: The intravenous blood of the patient was taken into 10-ml glaas-coated test tubes without anticoagulant solutions and rapidly centrifuged with a CGF centrifuge machine (Medifuge, Silfradent, S. Sofia, Italy). The instrument's CGF program was selected and operated at speeds and angles ranging from 2700 to 3000 rpm. After approximately 13 minutes of rotation, CGF was obtained. CGF is characterized by 4 phases: (1) serum in the top layer, (2) the second buffy coat layer, (3) the third GF and unipotent stem cell layer (CGF), (4) the lower red blood cell layer (RBC). The CGFand PRF clot was removed from the tube and separated from the RBC by using microsurgical scissors. The CGF was squeezed in a special box that produces membranes at a constant thickness of 1 mm.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
    Localized Gingival Recession
    Keywords
    localized gingival recession, Platelet rich fibrin, concentrated growth factor, coronally advanced flap

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (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
    Platelet Rich Fibrin
    Arm Type
    Active Comparator
    Arm Description
    Autogenous platelet and leukocyte fibrin material was obtained from blood.
    Intervention Type
    Procedure
    Intervention Name(s)
    Concentrated Growth Factor Membrane
    Other Intervention Name(s)
    An agent of platelet concentrates
    Intervention Description
    Concentrated growth factor 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)
    Platelet Rich Fibrin
    Other Intervention Name(s)
    An agent of platelet concentrates
    Intervention Description
    Platelet Rich Fibrinis produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
    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 of mean root coverage
    Description
    Change from baseline in percentage ofmean root coverage at 6th months.
    Time Frame
    6 months
    Title
    Keratinized gingiva width
    Description
    The distance is from the cemento-enamel junction 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

    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: systemically and periodontally healthy, non-smokers presence of 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

    Learn more about this trial

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