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Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG

Primary Purpose

Gingival Recession, Generalized

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
de-epithelized (DE) SCTG
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Generalized focused on measuring connective tissue, randomized controlled trial, gingival recession, patient outcome assessment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • systemically healthy patients between 18 and 70 years
  • clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars.

Exclusion Criteria:

  • abnormal teeth position
  • smokers, pregnant or nursing women
  • parafunctional habits
  • plaque and bleeding indexes (Ainamo & Bay, 1975) above 20%
  • previous periodontal surgeries on selected sites.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Clinical evaluation

    Laser Doppler Flowmetry

    Patient centered outcomes

    Arm Description

    Clinical periodontal parameters

    Laser Doppler Flowmetry evaluation

    Pain and discomfort/ Esthetics

    Outcomes

    Primary Outcome Measures

    Percentage of root coverage based on Recession depth at baseline and after 6 months
    Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

    Secondary Outcome Measures

    Variation on: Recession width (RW) comparing baseline measurements to 6 months.
    Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ
    Variation on: Probing depth (PD) comparing baseline measurements to 6 months.
    Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
    Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.
    Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
    Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.
    Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
    Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.
    Determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper (determined in mm).
    Pain and discomfort- Patient centered outcomes
    Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)
    Esthetics-Patient centered outcomes
    Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
    Esthetics-Periodontist evaluation
    Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)

    Full Information

    First Posted
    September 10, 2019
    Last Updated
    September 16, 2019
    Sponsor
    University of Sao Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04093674
    Brief Title
    Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG
    Official Title
    Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Double Blade Scalpel (DBS) and De-epithelized (DE) SCTG Associated With Coronally Advanced Flap (CAF): a Split-mouth Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    February 1, 2017 (Actual)
    Study Completion Date
    February 1, 2019 (Actual)

    3. Sponsor/Collaborators

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

    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
    This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.
    Detailed Description
    Clinical parameters and patient-centered outcomes Periodontal clinical examination was performed by a blind and calibrated examiner (intra-class correlation coefficient = 0.72) using a North Carolina periodontal probe (PCPUNC-Hu-Friedy®). Periodontal parameters were evaluated at baseline and after 6 months postoperatively and included: Recession depth (RD) - Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth; Recession width (RW) - Distance between interproximal gingival margins of GR with periodontal probe positioned at CEJ; Probing depth (PD) - Distance in millimeters from the gingival margin to the bottom of the gingival sulcus; Clinical attachment level (CAL) - Distance in millimeters from the CEJ to the bottom of the gingival sulcus; Keratinized tissue width (KTW) - Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth; Keratinized tissue thickness (KTT): determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper. The index proposed by Zucchelli & DeSanctis (2000) was used to calculate percentage of root coverage (%RC), as follows: RRC=(100.(RD baseline-RD 6 months))/(RD baseline) Patient centered outcomes and professional assessment were evaluated with visual analog scales (VAS). VAS was administered verbally to the patients to assess aesthetics and postoperative pain/discomfort. Patients were asked to make a mark in a scale between 0 (not satisfied or extreme pain) and 10 (very satisfied or no pain). Pain and discomfort were recorded after 7 days and patient´s aesthetic evaluation after 6 months. An experienced periodontist (intra-class correlation coefficient = 0.95) evaluated aesthetic outcome after 6 months. The Laser Doppler flowmetry (LDF) technique (VMS-LDF2 DUAL CHANNEL- Laser Doppler Blood Flow and Temperature Monitor (Moor instruments- process number-FAPESP 2012/13331-2) was used to evaluate blood flow on the recipient sites. LDF is equipped with a laser diode that emits in the infrared spectrum range (Maximum power - 2.5mW, wavelenghts 785nm±10nm). Measurements with LDF were performed with two probes for 1 minute and 30 seconds. These measurements were recorded three times for each site with intervals of one minute.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Generalized
    Keywords
    connective tissue, randomized controlled trial, gingival recession, patient outcome assessment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Split mouth
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinical evaluation
    Arm Type
    Experimental
    Arm Description
    Clinical periodontal parameters
    Arm Title
    Laser Doppler Flowmetry
    Arm Type
    Experimental
    Arm Description
    Laser Doppler Flowmetry evaluation
    Arm Title
    Patient centered outcomes
    Arm Type
    Experimental
    Arm Description
    Pain and discomfort/ Esthetics
    Intervention Type
    Procedure
    Intervention Name(s)
    de-epithelized (DE) SCTG
    Other Intervention Name(s)
    double blade scalpel (DBS) SCTG
    Intervention Description
    subepithelial connective tissue grafts
    Primary Outcome Measure Information:
    Title
    Percentage of root coverage based on Recession depth at baseline and after 6 months
    Description
    Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Variation on: Recession width (RW) comparing baseline measurements to 6 months.
    Description
    Recession width (RW) - Distance im milimeters between interproximal gingival margins of GR with periodontal probe positioned at CEJ
    Time Frame
    6 months
    Title
    Variation on: Probing depth (PD) comparing baseline measurements to 6 months.
    Description
    Distance in millimeters from the gingival margin to the bottom of the gingival sulcus;
    Time Frame
    6 months
    Title
    Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.
    Description
    Distance in millimeters from the CEJ to the bottom of the gingival sulcus;
    Time Frame
    6 months
    Title
    Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.
    Description
    Distance in millimeters from the gingival margin to the mucogingival junction measured at the midbuccal aspect of the tooth;
    Time Frame
    6 months
    Title
    Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.
    Description
    Determined 1.5 mm apically to gingival margin with an anesthesia needle and a rubber endodontic stop inserted perpendicularly into the soft tissue and measured with a digital caliper (determined in mm).
    Time Frame
    6 months
    Title
    Pain and discomfort- Patient centered outcomes
    Description
    Pain and discomfort assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (extreme pain) and 10 (no pain)
    Time Frame
    7 days
    Title
    Esthetics-Patient centered outcomes
    Description
    Esthetics assessed using Visual Analog Scale: Patients make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
    Time Frame
    6 months
    Title
    Esthetics-Periodontist evaluation
    Description
    Esthetics assessed using Visual Analog Scale: an experienced periodontist make a mark in a scale between 0 (not satisfied) and 10 (very satisfied)
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Laser doppler flowmetry
    Description
    The Laser Doppler flowmetry (LDF) technique (VMS-LDF2 DUAL CHANNEL- Laser Doppler Blood Flow and Temperature Monitor (Moor instruments- process number-FAPESP 2012/13331-2) was used to evaluate blood flow on the recipient sites. LDF is equipped with a laser diode that emits in the infrared spectrum range (Maximum power - 2.5mW, wavelenghts 785nm±10nm).
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: systemically healthy patients between 18 and 70 years clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars. Exclusion Criteria: abnormal teeth position smokers, pregnant or nursing women parafunctional habits plaque and bleeding indexes (Ainamo & Bay, 1975) above 20% previous periodontal surgeries on selected sites.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariana S Ragghianti Zangrando, Professor
    Organizational Affiliation
    Bauru School of Dentistry-University of Sao Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24640997
    Citation
    Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
    Results Reference
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    Clinical, Patient-centered Outcomes and Laser Doppler Flowmetry Using Two Types of SCTG

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