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Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap

Primary Purpose

Gingival Recession, Localized

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAF
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Localized focused on measuring gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness

Eligibility Criteria

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

Inclusion Criteria:

  • age >18 years,
  • no systemic diseases or pregnancy,
  • smoking ≤10 cigarettes/day,
  • full-mouth plaque score and full-mouth bleeding score ≤20%,
  • presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession,
  • recession depth (RD) equal to or greater than 2mm,
  • identifiable cemento-enamel junction (CEJ),
  • vital teeth, free from caries or prosthetic crown,

Exclusion Criteria:

  • systemic diseases or pregnancy,
  • history of periodontal surgery at experimental sites.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Split Full Split Elevation of CAF

    Split Elevation of CAF

    Arm Description

    The central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus

    The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus

    Outcomes

    Primary Outcome Measures

    CRC
    Percentages of recession with a Complete Root Coverage

    Secondary Outcome Measures

    RC
    percentages of Recession Coverage
    KTH
    Keratinized Tissue Height in mm.
    VAS discomfort
    patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)
    VAS esthetic
    patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).
    VAS satisfaction
    patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    January 31, 2018
    Sponsor
    University of Siena
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03417232
    Brief Title
    Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap
    Official Title
    Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap. A Double Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2013 (Actual)
    Primary Completion Date
    April 30, 2015 (Actual)
    Study Completion Date
    April 30, 2015 (Actual)

    3. Sponsor/Collaborators

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

    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
    Aim: to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion, comparing a "split-full-split" thickness flap elevation versus a "split" thickness approach performed during CAF for the treatment of isolated-type gingival recessions in the upper jaw. Material and Methods: forty patients were randomized, 20 were treated with "split-full-split" (test group) and 20 with a "split" approach (control group). Analyzed parameters at 1 year were: CRC, percentage of Recession Coverage (RC), Keratinized tissue (KT) gain, patient-related outcome measurements.
    Detailed Description
    Treatment of buccal gingival recession (GR) is the common clinical requirement from patients who are mainly concerned about aesthetics. Noteworthy are also requests linked to root sensitivity, difficulty in oral hygiene procedures, presence of root caries and non-carious cervical lesions. GR defects, when left untreated, do not improve spontaneously and may progress toward increased recession depth (RD) and clinical attachment loss which increase the patient's aesthetic concern and the clinical discomfort due to augmented dental hypersensitivity. Complete root coverage (CRC) can be considered the primary clinical outcome and selecting the surgical technique depends mainly on the local anatomical characteristics and on the patient's demands. In patients with a residual amount of keratinized tissue apical to the recession defect, the coronal advanced flap (CAF) may be recommended. This surgical technique results in optimal root coverage, good color blending of the treated area with respect to adjacent soft tissues and a complete recovery of the original (pre-surgical) soft tissue marginal morphology. Furthermore, post-operative morbidity is reduced to a single area of surgical intervention and the overall chair time is limited. When utilizing CAF technique, critical factors in CRC have been described in the literature. Flap positioning coronal to the CEJ and a tension-free flap design are among the most important ones. Moreover, flap thickness has been shown to influence the clinical outcomes of CAF procedure . Coronally advanced flap has been widely validated by the literature for the treatment of single recession defects and, currently, different flap designs and technical modifications are available to clinicians. De Sanctis and Zucchelli have recently introduced the "split-full-split" flap elevation modality. According to the authors, the modulation of flap thickness, produced by the inclusion of periosteum in the central area, increases flap thickness in the portion of the flap residing over the previously exposed avascular root surface. This, in turn, would give better stability to the flap. However, the partial-thickness flap approach is still commonly performed in the clinical practice and it is validated in the literature. To date, evidence is still lacking on the influence of including the periosteum in the flap when compared with a split thickness approach in obtaining a CRC. Thus, the aim of this double blind, controlled and randomized clinical trial was to evaluate the possible benefit on wound healing and flap stability of periosteum inclusion comparing a "split-full-split" flap elevation versus a "split" thickness approach when CAF is performed for the treatment of isolated-type gingival recessions in the upper jaw.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Localized
    Keywords
    gingival recession, coronally advanced flap, complete root coverage, flap elevation, flap thickness

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Split Full Split Elevation of CAF
    Arm Type
    Experimental
    Arm Description
    The central portion of the flap apical to the recession was elevated full thickness by the use of a small periostium elevator inserted into the probable sulcus
    Arm Title
    Split Elevation of CAF
    Arm Type
    Sham Comparator
    Arm Description
    The flap was fully elevated with a split thickness approach: the blade of the knife was inserted into the sulcus
    Intervention Type
    Procedure
    Intervention Name(s)
    CAF
    Intervention Description
    The design of the flap consisted of two horizontal beveled incisions (3mm in length) and two slightly oblique beveled incisions. The resulting trapezoidal-shaped flap was elevated in the coronal-apical direction. The suture of the flap started with two interrupted periosteal sutures performed at the most apical extension of the vertical releasing incisions; afterwards, it proceeded coronally with other interrupted sutures, each of them directed, from the flap to the adjacent buccal soft tissue, in the apical-coronal direction. The last sling suture allowed for the stabilization of the surgical papillae over the inter-dental connective tissue bed and allowed for a precise adaptation of the flap margin over the underlying convexity of the crown.
    Primary Outcome Measure Information:
    Title
    CRC
    Description
    Percentages of recession with a Complete Root Coverage
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    RC
    Description
    percentages of Recession Coverage
    Time Frame
    12 months
    Title
    KTH
    Description
    Keratinized Tissue Height in mm.
    Time Frame
    12 months
    Title
    VAS discomfort
    Description
    patient's discomfort expressed in a 10 cm Visual Analogue Scale, indicating discomfort from 0 (no discomfort) to 10 (maximum discomfort)
    Time Frame
    12 months
    Title
    VAS esthetic
    Description
    patient's esthetic expressed in a 10 cm Visual Analogue Scale, indicating esthetic from 0 (worst esthetic) to 10 (optimum esthetic).
    Time Frame
    12 months
    Title
    VAS satisfaction
    Description
    patient's satisfaction expressed in a 10 cm. Visual Analogue Scale, indicating satisfaction from 0 (no satisfaction) to 10 (good satisfaction).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age >18 years, no systemic diseases or pregnancy, smoking ≤10 cigarettes/day, full-mouth plaque score and full-mouth bleeding score ≤20%, presence of at least one Miller class I or II isolated recession defect (Miller, 1985) in the upper jaw and at least 2 mm of keratinized tissue apical to the recession, recession depth (RD) equal to or greater than 2mm, identifiable cemento-enamel junction (CEJ), vital teeth, free from caries or prosthetic crown, Exclusion Criteria: systemic diseases or pregnancy, history of periodontal surgery at experimental sites.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Massimo De Sanctis, MD
    Organizational Affiliation
    University of Siena
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30099762
    Citation
    Clementini M, Discepoli N, Danesi C, de Sanctis M. Biologically guided flap stability: the role of flap thickness including periosteum retention on the performance of the coronally advanced flap-A double-blind randomized clinical trial. J Clin Periodontol. 2018 Oct;45(10):1238-1246. doi: 10.1111/jcpe.12998. Epub 2018 Sep 14.
    Results Reference
    derived

    Learn more about this trial

    Biologically Guided Flap Stability: the Role of Periosteum Retention on the Performance of the Coronally Advanced Flap

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