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The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft

Primary Purpose

Gingival Recession, Atrophy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
free gingival graft
Sponsored by
Istanbul Aydın University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival biotype of adjacent teeth, free gingival graft, shrinkage of graft

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In the mandibular incisor tooth / teeth, the attached keratinized gingival width is <1 mm,
  • No periodontal surgery has been performed previously on the involved tooth.
  • In the absence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.
  • Do not use any of the drug groups that may cause gingival overgrowth.

Exclusion Criteria:

  • Previous periodontal surgery in the operation area
  • Restoration of the buccal surface of the tooth and no pathology in the apical region of the tooth.
  • In the presence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Arm Description

    Thin Biotype group has described as Group 1. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thin biotype, the patient was assigned to the thin biotype group.

    Thick biotype group has described as Group 2. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thick biotype, the patient was assigned to the thick biotype group.

    Outcomes

    Primary Outcome Measures

    The graft shrinkage ratio
    Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area

    Secondary Outcome Measures

    keratinized ginigival width
    Keratinized Gingival Width(KGW) was measured using a lugol solution (10% potassium iodide and 5% iodine) with a manual caliper spaced 0.5 mm from the mid-buccal point of the tooth, the distance between the gingival margin and mucogingival junction from MTT, DTT and the teeth/tooth in operation area.

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Istanbul Aydın University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03616197
    Brief Title
    The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft
    Official Title
    The Effect Of Different Gingival Biotypes On Dimensional Stability Of Free Gingival Graft: A Comparative 6 Month Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    April 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Aydın 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 is to compare the effect of mesial and distal adjacent gingival biotypes of the tooth / teeth region of free gingival graft (FGG) on the shrinkage ratio of graft at 6 months postoperatively.
    Detailed Description
    The concept of gingival and periodontal phenotype was established as a result of clinical observation of changes in facial keratinized tissue width and thickness .It has been reported that gingival or periodontal diseases may develop more frequently in patients with thin gingival biotypes and that thick-flat biotype in implant restorations is important in achieving a successful aesthetic treatment outcome. Free gingival graft (FGG) is a mucogingival surgical procedure that is successfully used in the presence of inadequate keratinized gingival width and gingival recession. It is thought that factors that may adversely affect the continuity of graft nutrition may be effective in graft shrinkage. These reasons can be listed as follows; graft thickness, traumatic surgical procedure, graft dehydration, and suturing procedure. There was no study investigating the effect of periodontal biotypes on graft contraction in the region adjacent to the FGG operation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Atrophy
    Keywords
    gingival biotype of adjacent teeth, free gingival graft, shrinkage of graft

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Determination of graft area measurements and shrinkage ratio of all photographs was performed by a periodontologist , an independent specialist who had not performed any surgical procedures.
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    Thin Biotype group has described as Group 1. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thin biotype, the patient was assigned to the thin biotype group.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    Thick biotype group has described as Group 2. The biotypes of the terminal teeth adjacent to the free gingival graft region were determined by the "Probe transparency method". The mesial terminal tooth (MTT) was defined as the first tooth adjacent to the mesial side of the tooth / teeth to which the FGG will be applied. The distal terminal tooth (DTT) was defined as the first tooth adjacent to the distal side of the tooth / teeth to which the FGG will be applied. If MTT and DTT had thick biotype, the patient was assigned to the thick biotype group.
    Intervention Type
    Procedure
    Intervention Name(s)
    free gingival graft
    Intervention Description
    A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.
    Primary Outcome Measure Information:
    Title
    The graft shrinkage ratio
    Description
    Graft shrinkage = Preoperative area - Postoperative area X 100 Preoperative area
    Time Frame
    baseline - 6th months postoperatively
    Secondary Outcome Measure Information:
    Title
    keratinized ginigival width
    Description
    Keratinized Gingival Width(KGW) was measured using a lugol solution (10% potassium iodide and 5% iodine) with a manual caliper spaced 0.5 mm from the mid-buccal point of the tooth, the distance between the gingival margin and mucogingival junction from MTT, DTT and the teeth/tooth in operation area.
    Time Frame
    baseline - 6th months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In the mandibular incisor tooth / teeth, the attached keratinized gingival width is <1 mm, No periodontal surgery has been performed previously on the involved tooth. In the absence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment. Do not use any of the drug groups that may cause gingival overgrowth. Exclusion Criteria: Previous periodontal surgery in the operation area Restoration of the buccal surface of the tooth and no pathology in the apical region of the tooth. In the presence of any systemic condition or illness (pregnancy, breastfeeding, mental retardation, diabetes, etc.) that may interfere with the patient's approval and dental treatment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    serap karakış akcan, Phd
    Organizational Affiliation
    İstanbul Aydın University, Faculty of Dentistry
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17294229
    Citation
    Hatipoglu H, Keceli HG, Guncu GN, Sengun D, Tozum TF. Vertical and horizontal dimensional evaluation of free gingival grafts in the anterior mandible: a case report series. Clin Oral Investig. 2007 Jun;11(2):107-13. doi: 10.1007/s00784-006-0084-x. Epub 2007 Feb 9.
    Results Reference
    background
    PubMed Identifier
    24494804
    Citation
    Gumus P, Buduneli E. Graft stabilization with cyanoacrylate decreases shrinkage of free gingival grafts. Aust Dent J. 2014 Mar;59(1):57-64. doi: 10.1111/adj.12149. Epub 2014 Feb 4.
    Results Reference
    result
    PubMed Identifier
    19431956
    Citation
    Barbosa FI, Correa DS, Zenobio EG, Costa FO, Shibli JA. Dimensional changes between free gingival grafts fixed with ethyl cyanoacrylate and silk sutures. J Int Acad Periodontol. 2009 Apr;11(2):170-6.
    Results Reference
    result

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    The Effect of Different Gingival Biotypes on Dimensional Stability of Free Gingival Graft

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