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Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions (PRP)

Primary Purpose

Gingival Recession, Generalized

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAF+ADM+PRP
CAF+ADM
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level

Eligibility Criteria

34 Years - 57 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
  2. must be able to have 2 mm-high keratinized tissue apical to the root exposures;
  3. must be able to have no systemic diseases that could influence the outcome of the therapy;
  4. must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
  5. must be non-smoker;
  6. must be not pregnant.

Exclusion Criteria:

  • debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
  • known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
  • taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
  • restorations or caries at the recession site;
  • failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
  • a previous periodontal surgery at the recession site and failure to complete the informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CAF+ADM+PRP

    CAF+ADM

    Arm Description

    Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)

    Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP

    Outcomes

    Primary Outcome Measures

    Root coverage (RC)
    The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.

    Secondary Outcome Measures

    Gingival recession depth (GRD)
    The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
    recession width (GRW)
    Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
    width of keratinized tissue (WKT)
    Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
    plaque index(PI)
    plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
    gingival index
    gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
    probing depth
    PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.

    Full Information

    First Posted
    February 2, 2017
    Last Updated
    February 6, 2017
    Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    Collaborators
    Gazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03043638
    Brief Title
    Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions
    Acronym
    PRP
    Official Title
    Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2008 (Actual)
    Primary Completion Date
    June 20, 2011 (Actual)
    Study Completion Date
    June 20, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
    Collaborators
    Gazi 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 aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs). 12 patients with 84 Miller Class I or II recession defects were participated. Sites were randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD), recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively. The data were analyzed statistically.
    Detailed Description
    Several methods have been demonstrated for the treatment of gingival recession defects with the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no significant difference between PRP and CTG treated groups in terms of root coverage of Miller Class 1 or II buccal recession defects. However, in the same study contour and texture of soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al. compared coronally positioned tunnel technique and ADM application with and without PRP for the treatment of single gingival recession defects and reported no statistically significant root coverage difference between groups. Although there are numerous root coverage procedures to treat the conditions, predictable coverage of multiple adjacent gingival recessions still remains a challenge for the clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus ADM application together with and without PRP to determine whether the PRP provided an advantage in terms of gaining coverage of deep and wide recession defects in the treatment of MAGRs. In the present study, using a controlled blinded split-mouth design, 14 patients with multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control groups respectively. Two patients who failed to return for all postoperative visits were exited from the study. Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm deep on non-molar teeth in the same dental arch at least two bilateral site, underwent through root coverage surgery and were followed for 12 months. The study sample consisted of 84 teeth associated with total of 12 patients; seven patients each showing a pair of three teeth, four patients each showing a pair of four teeth, and one patient showing a pair of five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD), clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing trauma to the gingival margin. Pre-surgical therapy included scaling, root planning, polishing and general oral hygiene instruction. All surgical procedures were performed with Coronally Advanced Flap technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Generalized
    Keywords
    multiple adjacent gingival recessions, platelet rich plasma, acellular dermal matrix, coronally advanced flap, gingival recession, root coverage, clinical attachment level

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAF+ADM+PRP
    Arm Type
    Experimental
    Arm Description
    Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)
    Arm Title
    CAF+ADM
    Arm Type
    Active Comparator
    Arm Description
    Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP
    Intervention Type
    Procedure
    Intervention Name(s)
    CAF+ADM+PRP
    Intervention Description
    CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.
    Intervention Type
    Procedure
    Intervention Name(s)
    CAF+ADM
    Intervention Description
    CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application
    Primary Outcome Measure Information:
    Title
    Root coverage (RC)
    Description
    The percentage of root coverage (RC) was calculated as ([GRD preoperation - GRD postoperation] / GRD preoperation) x 100%.
    Time Frame
    The change in RC at 3rd month to 12th month
    Secondary Outcome Measure Information:
    Title
    Gingival recession depth (GRD)
    Description
    The GRD was measured from the CEJ to the GM. PD, CAL and GRD were measured at the same reference points.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery
    Title
    recession width (GRW)
    Description
    Gingival recession width (GRW) was measured with perpendicular positioning of the periodontal probe to the cemento-enamel junction, the distance between the top of the papilla at the mesial and distal aspect of the tooth was recorded.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery
    Title
    width of keratinized tissue (WKT)
    Description
    Width of keratinized tissue (WKT) was measured at the mid-buccal point from the mucogingival junction (MGJ) to the free GM by a digital caliper.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery
    Title
    plaque index(PI)
    Description
    plaque index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery
    Title
    gingival index
    Description
    gingival index were calculated as a sum of mean scores by each examined tooth divided by the number of evaluated teeth. A mean of all measurements for each patient was considered.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery
    Title
    probing depth
    Description
    PD was measured at three points (mesio-buccal, midbuccal, and disto-buccal) on the individual elastomeric stent and calculated as the distance between gingival margin (GM) and the bottom of the sulcus.
    Time Frame
    Baseline, 3,6 and 12 months after periodontal surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    34 Years
    Maximum Age & Unit of Time
    57 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch must be able to have 2 mm-high keratinized tissue apical to the root exposures; must be able to have no systemic diseases that could influence the outcome of the therapy; must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972); must be non-smoker; must be not pregnant. Exclusion Criteria: debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium; known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis; taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ); restorations or caries at the recession site; failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse; a previous periodontal surgery at the recession site and failure to complete the informed consent.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pelin Gokalp
    Organizational Affiliation
    Gazi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    When needed data can be shared via email.
    Citations:
    PubMed Identifier
    19254123
    Citation
    Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.
    Results Reference
    background
    PubMed Identifier
    30895121
    Citation
    Cetiner D, Gokalp Kalabay P, Ozdemir B, Cankaya ZT. Efficiency of platelet-rich plasma on acellular dermal matrix application with coronally advanced flap in the treatment of multiple adjacent gingival recessions: A randomized controlled clinical trial. J Dent Sci. 2018 Sep;13(3):198-206. doi: 10.1016/j.jds.2017.11.002. Epub 2018 Feb 3.
    Results Reference
    derived

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    Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions

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