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Esthetic Outcomes of Single Immediate Implant Placement

Primary Purpose

Gingival Recession, Bone Loss, Alveolar

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flapless immediate implant placement
Flap assisted immediate implant placement
Implant and temporary crown
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Dental implants, surgical flap, esthetics, alveolar process

Eligibility Criteria

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

Inclusion Criteria:

  • Single non-restorable tooth in the anterior maxilla
  • Intact buccal plate or <5mm fenestration

Exclusion Criteria:

  • Pregnancy
  • Current smokers >10 cigarettes/day
  • Parafunctional habits
  • Malocclusion or intent of orthodontic therapy in the future
  • Severe periodontal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Flapless immediate implant placement group

    Flap assisted immediate implant placement group

    Arm Description

    Flapless placement of immediate implant and temporary crown

    Flap elevation prior to placement of immediate implant and temporary crown

    Outcomes

    Primary Outcome Measures

    Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline

    Secondary Outcome Measures

    Change in Buccal Horizontal Ridge Dimensions
    Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.
    Change in Interproximal Crestal Bone Levels

    Full Information

    First Posted
    April 15, 2015
    Last Updated
    April 26, 2019
    Sponsor
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02435706
    Brief Title
    Esthetic Outcomes of Single Immediate Implant Placement
    Official Title
    Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    August 9, 2016 (Actual)
    Study Completion Date
    August 9, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A randomized controlled trial of 12-month duration to compare gingival margin location, buccal horizontal ridge dimensions, and interproximal crestal bone levels following two surgical approaches for immediate placement of implants in the esthetic zone: one involving flap elevation and another using a flapless protocol.
    Detailed Description
    In the test group, the implant will be placed according to standard protocol at a position engaging the palatal wall without elevation of a mucoperiosteal flap. In the control group, intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the extraction site and full thickness flaps will be elevated with periosteal elevator, including the papillae. The implant will be placed according to standard protocol at a position engaging the palatal wall, and the flaps will be sutured using a combination of interrupted and mattress sutures. In both groups, temporary restorations will be delivered immediately after implant placement provided that the implant shows primary stability and has engaged in the bone with an insertion torque of 25Ncm or more. In case of a lower insertion torque, the protocol will be abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All patients will be advised to receive a permanent restoration 6 months after surgery, if the implant is deemed to be successful.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Bone Loss, Alveolar
    Keywords
    Dental implants, surgical flap, esthetics, alveolar process

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Flapless immediate implant placement group
    Arm Type
    Experimental
    Arm Description
    Flapless placement of immediate implant and temporary crown
    Arm Title
    Flap assisted immediate implant placement group
    Arm Type
    Active Comparator
    Arm Description
    Flap elevation prior to placement of immediate implant and temporary crown
    Intervention Type
    Procedure
    Intervention Name(s)
    Flapless immediate implant placement
    Intervention Description
    Experimental group: No elevation of flap prior to immediate implant placement
    Intervention Type
    Procedure
    Intervention Name(s)
    Flap assisted immediate implant placement
    Intervention Description
    Control group: Flap will be elevated prior to immediate implant placement
    Intervention Type
    Device
    Intervention Name(s)
    Implant and temporary crown
    Intervention Description
    Both groups receive this intervention
    Primary Outcome Measure Information:
    Title
    Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline
    Time Frame
    Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Buccal Horizontal Ridge Dimensions
    Description
    Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.
    Time Frame
    Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months
    Title
    Change in Interproximal Crestal Bone Levels
    Time Frame
    Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Single non-restorable tooth in the anterior maxilla Intact buccal plate or <5mm fenestration Exclusion Criteria: Pregnancy Current smokers >10 cigarettes/day Parafunctional habits Malocclusion or intent of orthodontic therapy in the future Severe periodontal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elena Sanz Miralles, DDS, MS, PhD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data were shared with The University of Texas Science Center at Houston (Dr. Chun-Teh Lee, formerly at Columbia University) in order to pursue further analysis of the data.
    IPD Sharing Time Frame
    April 2018. Data to be shared until the completion of the analysis of the data and publication of the results.
    IPD Sharing Access Criteria
    De-identified data corresponding to clinical and radiographic measurements were shared. Data were shared with Dr. Chun-teh Lee, a former investigator of the study who is currently working at The University of Texas Science Center at Houston.
    Citations:
    PubMed Identifier
    27501953
    Citation
    Stoupel J, Lee CT, Glick J, Sanz-Miralles E, Chiuzan C, Papapanou PN. Immediate implant placement and provisionalization in the aesthetic zone using a flapless or a flap-involving approach: a randomized controlled trial. J Clin Periodontol. 2016 Dec;43(12):1171-1179. doi: 10.1111/jcpe.12610. Epub 2016 Oct 17.
    Results Reference
    background
    PubMed Identifier
    24894299
    Citation
    Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
    Results Reference
    background

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    Esthetic Outcomes of Single Immediate Implant Placement

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