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Soft Tissue Thickness on Submerged and Non Submerged Implants

Primary Purpose

Tooth Loss, Edentulousness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implant
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 soft tissue thickness, dental implant, crestal bone loss

Eligibility Criteria

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

Inclusion Criteria:

  • being older than 18 years of age
  • generally healthy patients, no medical contraindication for implant surgery
  • missing teeth in upper jaw posterior and more than one tooth in neighbourhood area
  • no bone augmentation procedures before and during implant placement.

Exclusion Criteria:

  • poor oral hygiene
  • history of periodontitis
  • smoking
  • diabetes
  • alcoholism
  • taking medication which interferes soft and hard tissue healing
  • bruxism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Nonsubmerged thick group

    Nonsubmerged thin group

    Submerged thick group

    Submerged thin group

    Arm Description

    Nonsubmerged type of implants placed with thick (>3 mm) soft tissue

    Nonsubmerged type of implants placed with thin (<3 mm) soft tissue

    Submerged type of implants placed with thick (>3 mm) soft tissue

    Submerged type of implants placed with thin (<3 mm) soft tissue

    Outcomes

    Primary Outcome Measures

    Crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-4th month after placement
    Crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-6th month after placement
    Crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-12th month after placement
    Crestal bone loss
    Crestal bone loss was measured on radiographs between baseline-18th month after placement

    Secondary Outcome Measures

    Probing depth
    Probing depth was measured with a plastic periodontal probe at 4th month after placement
    Probing depth
    Probing depth was measured with a plastic periodontal probe at 6th month after placement
    Probing depth
    Probing depth was measured with a plastic periodontal probe at 12th month after placement
    Probing depth
    Probing depth was measured with a plastic periodontal probe at 18th month after placement
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe at 4th month after placement
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe at 6th month after placement
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe at 12th month after placement
    Keratinized tissue level
    Keratinized tissue level measured with a plastic periodontal probe at 18th month after placement
    Modified plaque index
    Modified plaque index was recorded at medial and distal surface of implants
    Modified plaque index
    Modified plaque index was recorded at medial and distal surface of implants
    Modified plaque index
    Modified plaque index was recorded at medial and distal surface of implants
    Modified plaque index
    Modified plaque index was recorded at medial and distal surface of implants
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded after 10 second of probing
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded after 10 second of probing
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded after 10 second of probing
    Modified sulcus bleeding index
    Modified sulcus bleeding index was recorded after 10 second of probing

    Full Information

    First Posted
    July 11, 2016
    Last Updated
    July 20, 2016
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02842385
    Brief Title
    Soft Tissue Thickness on Submerged and Non Submerged Implants
    Official Title
    The Influence of Soft Tissue Thickness On Crestal Bone Changes Around Submerged and Nonsubmerged Implants: A Randomized Prospective Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 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
    Changes in the marginal bone level surrounding the implant are the frequently used parameters in assessing the short- and long-term success. Multiple biological and biomechanical factors have been reported to adversely affect marginal bone level. Recently, initial vertical mucosal tissue thickness has also been reported to have an impact on bone stability.The hypothesis of present study is that soft tissue thickness on implant placement has no positive impact of crestal bone remodeling.
    Detailed Description
    The aim of this study is to evaluate the clinical and radiographical results of submerged and nonsubmerged implants with thin (<3 mm) and thick (>3 mm) soft tissue over 1.5 year after implant placement. All submerged and nonsubmerged implants were randomly placed as split-mouth. Clinical periodontal parameters were recorded. Crestal bone levels were analyzed from the day of implants inserted to 1.5 year after prosthetic loading on digitally standardized radiographs. 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, Edentulousness
    Keywords
    soft tissue thickness, dental implant, crestal bone loss

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Nonsubmerged thick group
    Arm Type
    Active Comparator
    Arm Description
    Nonsubmerged type of implants placed with thick (>3 mm) soft tissue
    Arm Title
    Nonsubmerged thin group
    Arm Type
    Active Comparator
    Arm Description
    Nonsubmerged type of implants placed with thin (<3 mm) soft tissue
    Arm Title
    Submerged thick group
    Arm Type
    Active Comparator
    Arm Description
    Submerged type of implants placed with thick (>3 mm) soft tissue
    Arm Title
    Submerged thin group
    Arm Type
    Active Comparator
    Arm Description
    Submerged type of implants placed with thin (<3 mm) soft tissue
    Intervention Type
    Other
    Intervention Name(s)
    Implant
    Intervention Description
    One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement
    Primary Outcome Measure Information:
    Title
    Crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-4th month after placement
    Time Frame
    Change from baseline crestal bone level at 4th month after placement,
    Title
    Crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-6th month after placement
    Time Frame
    Change from baseline crestal bone level at 6th month after placement,
    Title
    Crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-12th month after placement
    Time Frame
    Change from baseline crestal bone level at 12th month after placement,
    Title
    Crestal bone loss
    Description
    Crestal bone loss was measured on radiographs between baseline-18th month after placement
    Time Frame
    Change from baseline crestal bone level at 18th month after placement,
    Secondary Outcome Measure Information:
    Title
    Probing depth
    Description
    Probing depth was measured with a plastic periodontal probe at 4th month after placement
    Time Frame
    Evaluation of probing depth at 4th month after placement (mm)
    Title
    Probing depth
    Description
    Probing depth was measured with a plastic periodontal probe at 6th month after placement
    Time Frame
    Evaluation of probing depth at 6th month after placement (mm)
    Title
    Probing depth
    Description
    Probing depth was measured with a plastic periodontal probe at 12th month after placement
    Time Frame
    Evaluation of probing depth at 12th month after placement (mm)
    Title
    Probing depth
    Description
    Probing depth was measured with a plastic periodontal probe at 18th month after placement
    Time Frame
    Evaluation of probing depth at 18th month after placement (mm)
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe at 4th month after placement
    Time Frame
    Evaluation of keratinized tissue level at 4th month after placement (mm)
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe at 6th month after placement
    Time Frame
    Evaluation of keratinized tissue level at 6th month after placement (mm)
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe at 12th month after placement
    Time Frame
    Evaluation of keratinized tissue level at 12th month after placement (mm)
    Title
    Keratinized tissue level
    Description
    Keratinized tissue level measured with a plastic periodontal probe at 18th month after placement
    Time Frame
    Evaluation of keratinized tissue level at 18th month after placement (mm)
    Title
    Modified plaque index
    Description
    Modified plaque index was recorded at medial and distal surface of implants
    Time Frame
    Modified plaque index was recorded at 4th month after implant placement
    Title
    Modified plaque index
    Description
    Modified plaque index was recorded at medial and distal surface of implants
    Time Frame
    Modified plaque index was recorded at 6th month after implant placement
    Title
    Modified plaque index
    Description
    Modified plaque index was recorded at medial and distal surface of implants
    Time Frame
    Modified plaque index was recorded at 12th month after implant placement
    Title
    Modified plaque index
    Description
    Modified plaque index was recorded at medial and distal surface of implants
    Time Frame
    Modified plaque index was recorded at 18th month after implant placement
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded after 10 second of probing
    Time Frame
    Modified sulcus bleeding index was recorded at 4th month after implant placement
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded after 10 second of probing
    Time Frame
    Modified sulcus bleeding index was recorded at 6th month after implant placement
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded after 10 second of probing
    Time Frame
    Modified sulcus bleeding index was recorded at 12th month after implant placement
    Title
    Modified sulcus bleeding index
    Description
    Modified sulcus bleeding index was recorded after 10 second of probing
    Time Frame
    Modified sulcus bleeding index was recorded at 18th month after implant placement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: being older than 18 years of age generally healthy patients, no medical contraindication for implant surgery missing teeth in upper jaw posterior and more than one tooth in neighbourhood area no bone augmentation procedures before and during implant placement. Exclusion Criteria: poor oral hygiene history of periodontitis smoking diabetes alcoholism taking medication which interferes soft and hard tissue healing bruxism.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deniz Cengiz Özkaya, PhD,DDS
    Organizational Affiliation
    Ege University, School of Dentistry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Soft Tissue Thickness on Submerged and Non Submerged Implants

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