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A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SCTG+EMD
SCTG
Sponsored by
Hacer Sahin Aydinyurt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival recession, Subepithelial connective tissue grafts, CAD/CAM

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • individuals should have no systemic disease
  • non-smokers of cigarette or tobacco products
  • not in a pregnancy,
  • have not used any antibiotics or medications with an impact on the immune system within last 6 months,
  • have GR classified as Miller class I or class II
  • have GR depth of ≥2mm ,
  • have no decay or restoration on the vital teeth which will be operated
  • have no operation history with regard to GRs for related tooth area.

Exclusion Criteria:

  • pregnancy
  • smoking
  • Miller class III and IV gingival recession
  • antibiotic use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    test group

    control group

    Arm Description

    Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.

    Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used

    Outcomes

    Primary Outcome Measures

    GGV
    Gingival gain volume: measured by software on images (mm3)
    GGSA
    Gingival gain of surface area: measured by software on images (mm2
    GRH
    gingival recession height: the distance between cementoenamel junction to gingival margin (mm)
    GRW
    gingival recession width: the distance between mesial and distal gingival margins (mm)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2017
    Last Updated
    September 24, 2017
    Sponsor
    Hacer Sahin Aydinyurt
    Collaborators
    Yuzuncu Yıl University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03295604
    Brief Title
    A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment
    Official Title
    A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (Actual)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Hacer Sahin Aydinyurt
    Collaborators
    Yuzuncu Yıl 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
    Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices. Materials and Methods: A total of 35 Miller class I-II gingival recession defects were involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM system before the treatment, at the 1st month and at the 6th months after the treatment. The images were superimposed using softwares and GGV, GGSA were calculated.
    Detailed Description
    Study populations: In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with complaints of poor aesthetic and/or root surface sensitivity. Following patients were admitted to the study: individuals should have no systemic disease, should be non-smokers of cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or medications with an impact on the immune system within last 6 months, have GR classified as Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital teeth which will be operated, have no operation history with regard to GRs for related tooth area. The materials and methods of this study were approved by the Non-Drug Clinical Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32). Study Groups: In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann, Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign them into groups. Pre-surgical Procedure: Patients were informed about the potential causes of GRs. Causative habits of GR have been eliminated. Baseline periodontal treatments of the patients were performed. Plaque index (PI) , gingival index (GI) , probing pocket depth (PPD) (mm), clinical attachment level (CAL) (mm) were recorded before periodontal treatment. We prepared patients with total PI scores less than 15% for the surgical procedure (O'Leary et al 1972). Pre-treatment 3D soft tissue images were taken by CEREC Omnicam (Sirona Dental Systems GmbH, Bensheim, Germany) from intra-oral region. Recipient zone was prepared using the Langer method. SCTG was extracted ipsilaterally with the operation site from the palatal region between distal of canine and mesial of 1st molar tooth. Incision was performed in parallel with free gingival margin using Harris graft knife (Harris Double Blade Graft Knife, H & H Company, Ontario, CA, USA). Harvested graft was implanted to recipient zone so that its periosteal side faces with root surface and overhangs defect borders by 1mm. In order to remove the smear layer on the root surface of the teeth in SCTG+EMD group, 24% EDTA (Prefgel, Straumann, Basel, Switzerland) was applied for two minutes onto the root surface and operation site was washed with normal saline in order to remove any residual EDTA. EMD was applied to entire root surface compatible with manufacturer's instructions . Post-surgical Procedure: 3D images and clinical parameter values were recorded during follow-up examinations at the 1st and the 6th month after the periodontal surgery. 3D images of soft tissue were taken intraorally with CEREC Omnicam® device at the commencement of treatment as well as at the post-operative 1st and 6th months . The measurements were recorded as in rst.img format which is a file extension of CEREC system®. The operation site was cut out from the image which was recorded at the 1st and at the 6th month. Images of each patient which were taken in three different time points were overlapped on Mimics 10 software. GGV and GGSA measurements were made on the overlapped images. the GGV and GGSA were calculated the difference in tissue as obtained after overlapping the 3D images by the software. Changes at the 1st and the 6th month after treatment were calculated with respect to pre-treatment images .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession
    Keywords
    Gingival recession, Subepithelial connective tissue grafts, CAD/CAM

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    test group
    Arm Type
    Experimental
    Arm Description
    Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.
    Arm Title
    control group
    Arm Type
    Experimental
    Arm Description
    Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used
    Intervention Type
    Procedure
    Intervention Name(s)
    SCTG+EMD
    Intervention Description
    Miller class I-II gingival recession defects were operated with SCTG+EMD
    Intervention Type
    Procedure
    Intervention Name(s)
    SCTG
    Intervention Description
    Miller class I-II gingival recession defects were operated with SCTG only and
    Primary Outcome Measure Information:
    Title
    GGV
    Description
    Gingival gain volume: measured by software on images (mm3)
    Time Frame
    6 months
    Title
    GGSA
    Description
    Gingival gain of surface area: measured by software on images (mm2
    Time Frame
    6 months
    Title
    GRH
    Description
    gingival recession height: the distance between cementoenamel junction to gingival margin (mm)
    Time Frame
    6 months
    Title
    GRW
    Description
    gingival recession width: the distance between mesial and distal gingival margins (mm)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: individuals should have no systemic disease non-smokers of cigarette or tobacco products not in a pregnancy, have not used any antibiotics or medications with an impact on the immune system within last 6 months, have GR classified as Miller class I or class II have GR depth of ≥2mm , have no decay or restoration on the vital teeth which will be operated have no operation history with regard to GRs for related tooth area. Exclusion Criteria: pregnancy smoking Miller class III and IV gingival recession antibiotic use

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment

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