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Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial

Primary Purpose

Tooth Loss, Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
papilla fill index
crestal bone loss
probing depth
Modified sulcus bleeding index
Modified plaque index
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery

Eligibility Criteria

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

Inclusion Criteria:

  • No sistemic condition, and age > 18 years,
  • healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%,
  • in a need of at least two collateral implants in the maxilla from second premolar to second premolar
  • sufficient keratinized tissue
  • no bone augmentation procedures before implant placement
  • use of tobacco 10N ≥ cigarettes daily
  • sufficient distance between opposite occluding dentition at the proposed implant sites

Exclusion Criteria:

  • history of aggressive periodontitis,
  • systemic diseases such as diabetes
  • pregnant or lactating women
  • radiation therapy in the head and neck area wihtin the previous 12 months,
  • heavy smokers
  • bruxism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Test group- ı shape incision

    Control group- midcrestal incision

    Arm Description

    Second stage surgery was made I shape incision technique .

    In the control group second stage surgery was made using the conventional method, midcrestal technique.

    Outcomes

    Primary Outcome Measures

    papilla fill index
    Baseline will be 1 week after cementation of the crowns.
    papilla fill index
    Papilla fill index will be recorded 3rd month after baseline
    papilla fill index
    Papilla fill index will be recorded 6th month after baseline
    crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-3rd month.
    crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-6th month.
    vertical distance
    Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.

    Secondary Outcome Measures

    Probing depth
    The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
    Probing depth
    The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
    Probing depth
    The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Modified plaque index
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Modified plaque index
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Modified plaque index
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe

    Full Information

    First Posted
    December 8, 2016
    Last Updated
    December 14, 2016
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02996370
    Brief Title
    Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
    Official Title
    Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    September 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Regenerating a predictable inter-implant papilla is the most complex and challenging aspect of implant dentistry. The aim of the study was to compare the efficacy of I shaped incision technique and conventional midcrestal incision technique for interimplant papilla reconstruction in a 6 month clinical trial.
    Detailed Description
    A total of 40 implants were placed in 12 patients. Groups were determined at second stage surgery, I shape technique used in test group and mid-crestal technique used in control group. The clinical parameters, including modified plaque index, modified sulcus bleeding index, probing depth, keratinized tissue level were recorded baseline, 3 and 6 month. The vertical distance between the crests top-contact point was evaluated with digital periapical radiographs at baseline 3 and 6 month. Also the clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images. With these images the ratio of the papilla area in proportion to the embrasure area and the papilla classification was measured. Non-parametric test were used for statistically analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Loss, Bone Loss
    Keywords
    esthetic, inter-implant papilla, soft tissue tickness, crestal bone loss, second stage surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group- ı shape incision
    Arm Type
    Active Comparator
    Arm Description
    Second stage surgery was made I shape incision technique .
    Arm Title
    Control group- midcrestal incision
    Arm Type
    Active Comparator
    Arm Description
    In the control group second stage surgery was made using the conventional method, midcrestal technique.
    Intervention Type
    Other
    Intervention Name(s)
    papilla fill index
    Intervention Description
    The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.
    Intervention Type
    Other
    Intervention Name(s)
    crestal bone loss
    Intervention Description
    Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
    Intervention Type
    Other
    Intervention Name(s)
    probing depth
    Intervention Description
    The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
    Intervention Type
    Other
    Intervention Name(s)
    Modified sulcus bleeding index
    Intervention Description
    Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
    Intervention Type
    Other
    Intervention Name(s)
    Modified plaque index
    Intervention Description
    Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
    Primary Outcome Measure Information:
    Title
    papilla fill index
    Description
    Baseline will be 1 week after cementation of the crowns.
    Time Frame
    baseline
    Title
    papilla fill index
    Description
    Papilla fill index will be recorded 3rd month after baseline
    Time Frame
    3 month
    Title
    papilla fill index
    Description
    Papilla fill index will be recorded 6th month after baseline
    Time Frame
    6 month
    Title
    crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-3rd month.
    Time Frame
    Change from baseline crestal bone level up to 3 months
    Title
    crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-6th month.
    Time Frame
    Change from baseline crestal bone level up to 6 months
    Title
    vertical distance
    Description
    Inter-implant vertical distance between the crests top-contact point was also evaluated with digital periapical radiographs.
    Time Frame
    baseline, 3 and 6 month
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
    Time Frame
    baseline
    Title
    Probing depth
    Description
    The level of probing depth at 3 month. Probing depth was measured with a plastic periodontal probe.
    Time Frame
    3 month
    Title
    Probing depth
    Description
    The level of probing depth at 6 month. Probing depth was measured with a plastic periodontal probe.
    Time Frame
    6 month
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Time Frame
    Modified sulcus bleeding index was recorded at baseline
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Time Frame
    Modified sulcus bleeding index was recorded at 3 month
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded at four sites of implants after 10 sec. of probing.
    Time Frame
    Modified sulcus bleeding index was recorded at 6 month
    Title
    Modified plaque index
    Description
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Time Frame
    Modified plaque index was recorded at baseline
    Title
    Modified plaque index
    Description
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Time Frame
    Modified plaque index was recorded at 3 month
    Title
    Modified plaque index
    Description
    The dichotomous presence of supra gingival plaque was recorded at four sites of implants
    Time Frame
    Modified plaque index was recorded at 6 month
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe
    Time Frame
    Keratinized tissue level was recorded at baseline
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe
    Time Frame
    Keratinized tissue level was recorded at 3 month
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe
    Time Frame
    Keratinized tissue level was recorded at 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: No sistemic condition, and age > 18 years, healthy soft tissue (bleeding on probing (BOP) ≤ 20%, Plaque Index ≤ 15%, in a need of at least two collateral implants in the maxilla from second premolar to second premolar sufficient keratinized tissue no bone augmentation procedures before implant placement use of tobacco 10N ≥ cigarettes daily sufficient distance between opposite occluding dentition at the proposed implant sites Exclusion Criteria: history of aggressive periodontitis, systemic diseases such as diabetes pregnant or lactating women radiation therapy in the head and neck area wihtin the previous 12 months, heavy smokers bruxism.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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