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Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions

Primary Purpose

Gingival Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Horizontal incisions
Oblique incisions
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Systemically healthy subjects
  • Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla).
  • At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) > 3 mm.
  • Full-mouth plaque and bleeding on probing of < 20%.
  • Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion.

Exclusion Criteria:

  • History of smoking.
  • Antimicrobial and anti-inflammatory therapies in the previous 2 months.
  • Previous mucogingival surgery at the region to be treated
  • Systemic conditions that could affect tissue healing (e.g. diabetes).
  • Use of orthodontic appliances.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Horizontal incisions

    Oblique incisions

    Arm Description

    Coronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.

    Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.

    Outcomes

    Primary Outcome Measures

    Change from baseline in Marginal gingival recession to 6 months

    Secondary Outcome Measures

    height of keratinized tissue
    thickness of keratinized tissue
    Clinical attachment level
    Probing deph

    Full Information

    First Posted
    August 21, 2014
    Last Updated
    August 28, 2014
    Sponsor
    Paulista University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02229669
    Brief Title
    Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions
    Official Title
    Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions: A Split-mouth RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study compared the clinical outcomes of coronally advanced flap using two different surgical strategies in the treatment of multiple gingival recessions.
    Detailed Description
    The objective of this split-mouth, randomized controlled trial was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Recessions were randomly treated according to a split-mouth design by means of: CAF with oblique interdental incisions (OBL technique) or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT) and thickness of keratinized tissue (TKT) were measured at baseline, 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a Visual Analogue Scale (VAS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Horizontal incisions
    Arm Type
    Experimental
    Arm Description
    Coronally advanced flap was performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted extending beyond the mucogingival junction, to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed.
    Arm Title
    Oblique incisions
    Arm Type
    Experimental
    Arm Description
    Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Horizontal incisions
    Intervention Description
    Performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Oblique incisions
    Intervention Description
    Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
    Primary Outcome Measure Information:
    Title
    Change from baseline in Marginal gingival recession to 6 months
    Time Frame
    baseline, and at 3 and 6 months post-surgery
    Secondary Outcome Measure Information:
    Title
    height of keratinized tissue
    Time Frame
    Baseline, 3 and 6 months
    Title
    thickness of keratinized tissue
    Time Frame
    baseline, 3 and 6 months
    Title
    Clinical attachment level
    Time Frame
    baseline, 3 and 6 months
    Title
    Probing deph
    Time Frame
    baseline, 3 and 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Systemically healthy subjects Patients should have bilateral Class I and II MGRs (Miller 1985) in maxillary tooth (at least three recession-type defects affecting adjacent teeth in each side of the maxilla). At least 20 teeth and no sites with attachment loss and probing pocket depth (PPD) > 3 mm. Full-mouth plaque and bleeding on probing of < 20%. Involved tooth should present tooth vitality, absence of caries, restorations or extensive non-carious cervical lesion. Exclusion Criteria: History of smoking. Antimicrobial and anti-inflammatory therapies in the previous 2 months. Previous mucogingival surgery at the region to be treated Systemic conditions that could affect tissue healing (e.g. diabetes). Use of orthodontic appliances.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suzana Pimentel, PHD
    Organizational Affiliation
    Paulista University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Guilherme Barrella, MS
    Organizational Affiliation
    Paulista University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Coronally Advanced Flap With Two Different Techniques for the Treatment of Multiple Gingival Recessions

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