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Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap
hyaluronic acid
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, clinical trial(s).

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 18 years
  • full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth)
  • presence of at least one buccal recession (depth ≥2 mm) classified as Miller Class I. Only gingival recession sites localized in the anterior area of the maxillary or mandibular arch (central and lateral incisors, canine and first and second premolars) and associated with aesthetic problems and/or dental hypersensitivity were enclosed
  • gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession
  • presence of a clearly identifiable cemento-enamel junction (CEJ), 10) no teeth with prosthetic crown or restoration with the cervical edge in the CEJ area

Exclusion Criteria:

  • systemic diseases or pregnancy
  • smokers
  • systemic antibiotic therapy in the last 6 months
  • active periodontal disease with a sites (probing pocket depth <4 mm and no bleeding on probing)
  • history of mucogingival or periodontal surgery at the experimental site

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CAF + HA (Test)

    CAF (control)

    Arm Description

    coronally advanced flap with hyaluronic acid

    coronally advanced flap alone

    Outcomes

    Primary Outcome Measures

    Recession reduction (RecRed)
    Changes in recession depth between initial and final. Measured in mm

    Secondary Outcome Measures

    Post-operative morbidity (pain, swelling and discomfort)
    With an evaluation questionnaire. The interviewer assessed patient's pain, swelling and discomfort at 7 days after procedure using visual analogue scale (VAS) ranging from 0 (no pain/swelling/discomfort) to 10 (maximal pain/swelling/discomfort).
    Complete root coverage (CRC)
    Assessed as percentage of sites with complete root coverage
    Mean root coverage (MRC)
    Assessed as percentage of mean root coverage for each group.
    Probing pocket depth (PPD)
    Changes in PPD between initial and final. Measured in mm
    Clinical attachment level gain (CAL-Gain)
    Difference between CAL initial and final. Measured in mm
    Width of keratinized tissue (KT)
    Changes in KT between initial and final. Measured in mm

    Full Information

    First Posted
    June 25, 2017
    Last Updated
    June 27, 2017
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03204565
    Brief Title
    Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites
    Official Title
    Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Miller Class I Single Gingival Recession Sites
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (Actual)
    Primary Completion Date
    April 3, 2017 (Actual)
    Study Completion Date
    April 24, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) in combination with the coronally advanced flap (CAF) for the treatment of single gingival recession site. The hypothesis is that HA will result in improved the clinical outcomes and will reduce the pos-operative morbidity
    Detailed Description
    Gingival recession is a common clinical finding in patients with high standards of oral hygiene and can be found in more than 90% of patients. Buccal exposure of roots with aesthetic impairments and dentinal hypersensitivity The ultimate goal of root coverage procedures is the complete coverage of the recession defect with an aesthetic appearance comparable to adjacent healthy soft tissues in combination with physiological probing pocket depths.Several surgical techniques have already provided good results and have been shown to attain root coverage at individual recession sites these different methods.To date, connective tissue grafts (CTG) and enamel matrix derivatives (EMD) in conjunction with a coronally advanced flap (CAF) have been shown to provide the highest probability of obtaining complete root coverage (CRC) in Miller class I and II single gingival recession as compared to CAF alone. Hyaluronic acid (HA) is a major component of the extracellular matrix in almost all tissues. The primary role of HA is to bind water and to permit the transportation of key metabolites and therefore to maintain the structural and homeostatic integrity of these tissues. In vitro and animal studies have demonstrated that hyaluronic acid have many properties that are essential for tissue regeneration and wound healing. However, to the best of our knowledge, there have been limited clinical application studies in the field of root coverage procedures performed and still no consistent published data with longer follow-ups on the usage of HA are available. Therefore, the aim of this randomized controlled clinical trial (RCT) was to evaluate the potential benefit of the adjunctive use of HA in combination with a coronally advanced flap (CAF) and to compare the outcomes with CAF alone, when treating single Miller Class I gingival recessions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    gingival recession, clinical trial(s).

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    CAF + HA (Test)
    Arm Type
    Experimental
    Arm Description
    coronally advanced flap with hyaluronic acid
    Arm Title
    CAF (control)
    Arm Type
    Active Comparator
    Arm Description
    coronally advanced flap alone
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap
    Intervention Description
    coronally advanced flap alone (CAF- control)
    Intervention Type
    Device
    Intervention Name(s)
    hyaluronic acid
    Intervention Description
    hyaluronic acid associated to coronally advanced flap (CAF + HA- test)
    Primary Outcome Measure Information:
    Title
    Recession reduction (RecRed)
    Description
    Changes in recession depth between initial and final. Measured in mm
    Time Frame
    baseline and 18 months
    Secondary Outcome Measure Information:
    Title
    Post-operative morbidity (pain, swelling and discomfort)
    Description
    With an evaluation questionnaire. The interviewer assessed patient's pain, swelling and discomfort at 7 days after procedure using visual analogue scale (VAS) ranging from 0 (no pain/swelling/discomfort) to 10 (maximal pain/swelling/discomfort).
    Time Frame
    7 days
    Title
    Complete root coverage (CRC)
    Description
    Assessed as percentage of sites with complete root coverage
    Time Frame
    18 months
    Title
    Mean root coverage (MRC)
    Description
    Assessed as percentage of mean root coverage for each group.
    Time Frame
    18 months
    Title
    Probing pocket depth (PPD)
    Description
    Changes in PPD between initial and final. Measured in mm
    Time Frame
    baseline and 18 months
    Title
    Clinical attachment level gain (CAL-Gain)
    Description
    Difference between CAL initial and final. Measured in mm
    Time Frame
    baseline and 18 months
    Title
    Width of keratinized tissue (KT)
    Description
    Changes in KT between initial and final. Measured in mm
    Time Frame
    baseline and 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥ 18 years full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth) presence of at least one buccal recession (depth ≥2 mm) classified as Miller Class I. Only gingival recession sites localized in the anterior area of the maxillary or mandibular arch (central and lateral incisors, canine and first and second premolars) and associated with aesthetic problems and/or dental hypersensitivity were enclosed gingival recession with at least 1 mm of keratinized tissue (KT) apical to the recession presence of a clearly identifiable cemento-enamel junction (CEJ), 10) no teeth with prosthetic crown or restoration with the cervical edge in the CEJ area Exclusion Criteria: systemic diseases or pregnancy smokers systemic antibiotic therapy in the last 6 months active periodontal disease with a sites (probing pocket depth <4 mm and no bleeding on probing) history of mucogingival or periodontal surgery at the experimental site
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrea Pilloni, MD,DDS,MS
    Organizational Affiliation
    University La Sapienza, Rome
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11989392
    Citation
    Moseley R, Waddington RJ, Embery G. Hyaluronan and its potential role in periodontal healing. Dent Update. 2002 Apr;29(3):144-8. doi: 10.12968/denu.2002.29.3.144.
    Results Reference
    background
    PubMed Identifier
    24641000
    Citation
    Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
    Results Reference
    background
    PubMed Identifier
    17209788
    Citation
    Pilloni A, Paolantonio M, Camargo PM. Root coverage with a coronally positioned flap used in combination with enamel matrix derivative: 18-month clinical evaluation. J Periodontol. 2006 Dec;77(12):2031-9. doi: 10.1902/jop.2006.050390.
    Results Reference
    background
    PubMed Identifier
    25315018
    Citation
    Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
    Results Reference
    background
    PubMed Identifier
    25624632
    Citation
    Kumar R, Srinivas M, Pai J, Suragimath G, Prasad K, Polepalle T. Efficacy of hyaluronic acid (hyaluronan) in root coverage procedures as an adjunct to coronally advanced flap in Millers Class I recession: A clinical study. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):746-50. doi: 10.4103/0972-124X.147411.
    Results Reference
    background
    PubMed Identifier
    21884772
    Citation
    Ferguson EL, Roberts JL, Moseley R, Griffiths PC, Thomas DW. Evaluation of the physical and biological properties of hyaluronan and hyaluronan fragments. Int J Pharm. 2011 Nov 25;420(1):84-92. doi: 10.1016/j.ijpharm.2011.08.031. Epub 2011 Aug 22.
    Results Reference
    background
    PubMed Identifier
    10231509
    Citation
    Chen WY, Abatangelo G. Functions of hyaluronan in wound repair. Wound Repair Regen. 1999 Mar-Apr;7(2):79-89. doi: 10.1046/j.1524-475x.1999.00079.x.
    Results Reference
    background
    PubMed Identifier
    2855633
    Citation
    Weigel PH, Frost SJ, McGary CT, LeBoeuf RD. The role of hyaluronic acid in inflammation and wound healing. Int J Tissue React. 1988;10(6):355-65.
    Results Reference
    background

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    Effectiveness of Adjunctive Hyaluronic Acid Application in Coronally Advanced Flap in Single Gingival Recession Sites

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