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Platform Switched Implant and Bone Level Alteration

Primary Purpose

Edentulous, Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subcrestal implant placement
Paracrestal implant placement
prophylactic antibiotics
dental implant
x-ray examination
Sponsored by
Beijing University Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous focused on measuring platform switching, crestal bone remodeling, soft tissue thickness, dental implant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • lose of two posterior teeth more than 3 months
  • generally healthy (ASA score I)
  • non-smoking
  • periodontally healthy
  • sufficient bone volume to place an implant without augmentation procedure

Exclusion Criteria:

  • medical and/or psychiatric contraindication to dental implant restoration
  • local infection
  • pregnancy or lactating
  • poor oral hygiene
  • tissue deficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Subcrestal

    Paracrestal

    Arm Description

    implants that are placed below the alveolar ridge

    implants that are placed flush to the alveolar ridge

    Outcomes

    Primary Outcome Measures

    Changes of marginal bone levels of dental implant
    Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.

    Secondary Outcome Measures

    Bleeding on probing(BOP)
    bleeding index whiling probing the implant restorations
    Probing pocket depth(PPD)
    probing depth of implant supported restorations
    modified plaque index(PI)
    Modified plaque index to evaluate the oral hygiene conditions

    Full Information

    First Posted
    July 24, 2016
    Last Updated
    August 13, 2016
    Sponsor
    Beijing University Health Science Center
    Collaborators
    Dentsply Sirona Implants and Consumables
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02867982
    Brief Title
    Platform Switched Implant and Bone Level Alteration
    Official Title
    Influence of Soft Tissue Thickness and Insertion Depth of Platform Switched Implants on Crestal Bone Level Alteration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing University Health Science Center
    Collaborators
    Dentsply Sirona Implants and Consumables

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a two-year prospective randomized clinical study to to evaluate whether the gingival thickness and insertion depth of dental implants have any influence on marginal bone levels changes around platform switched implants.
    Detailed Description
    Patient selection: Patients at the Department of Oral Implantology, Peking University School and Hospital of stomatology, Bei Jing, China, who seek for implant restoration for two continous posterior teeth are potentially recruited. Inclusion criteria are generally healthy (ASA score I), non-smoking, periodontally healthy, and sufficient bone volume to place an implant without augmentation procedure. Patients were excluded in cases of medical and/or psychiatric contraindications, local infection, pregnancy or lactating, poor oral hygiene, tissue deficiency, or not willing to participate in this study. Randomization: The two implant sites of each subject are randomly assigned to two different group with a predefined randomization tables. In order to reduce the chance of unfavorable splits between groups in terms of key prognostic factors,the randomization process will take into account the following variables: patient's gender, age, presence of adjacent teeth, distal extension sites and site location in the dental arch. Assignment will perform using a sealed envelope. Surgical protocol: Before the surgical procedure, prophylactic antibiotics of 1g amoxicillin will prescribed to the patient 1 h before surgery, and continued with 2 g/day for 6 days. After crestal incision, full thickness buccal flap was raised, whereas lingual part was not elevated. Thickness of soft tissues was measured with 1.0-mm marked periodontal probe on the top of bone crest in the center of the two future implant sites. This ensured direct visibility of mucosal thickness during measurement. After measurements, full-thickness lingual flap is raised and subsequent implant osteotomy is finished, Two dental implants (Dentsply Implants Manufacturing GmbH, Mannheim, Germany) with diameter of 3.5 mm are ready to torch into the bone cavities. In one site (group 1), the platform of implants are placed at the crestal level (flush to the alveolar ridge) . In the other site (group 2), the implants are placed 1mm below the alveolar ridge. narrow healing abutment are connected to all the implants. The flap are repositioned and closed with interrupted single sutures. Implants are allowed for a un-submerged healing. 3 month after healing, the implant level impressions are taken, splinted restorations of two neighbouring posterior teeth are delivered 2 weeks later. Radiographic and Clinical Examination: All the patients are required for recall visit at 3, 6,12 months and 2 years post surgery. A digital peri-apical radiograph was taken at the 1 year and 2year follow-up examination for bone level evaluation using a film holder to aim the x-ray beam perpendicular to the implant threads, and the implant length is used as calibration for the measurement. Using a image analysis software (ImageJ, version 1.47, NIH, Bethesda, MD, USA), the investigators are able to have an accurate assessment of the crest of bone and to analyze the bone changes over period of time. Bone loss was defined as a positive value and bone gain as a negative one. Mean values, standard deviations, and maximum and minimum values were calculated. Furthermore, periodontal parameters [bleeding on probing (BOP), probing pocket depth (PPD), modified plaque index on adjacent teeth and implants] were assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous, Bone Resorption
    Keywords
    platform switching, crestal bone remodeling, soft tissue thickness, dental implant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subcrestal
    Arm Type
    Other
    Arm Description
    implants that are placed below the alveolar ridge
    Arm Title
    Paracrestal
    Arm Type
    Other
    Arm Description
    implants that are placed flush to the alveolar ridge
    Intervention Type
    Procedure
    Intervention Name(s)
    Subcrestal implant placement
    Intervention Description
    Dental implants placed 2 mm below the alveolar ridge
    Intervention Type
    Procedure
    Intervention Name(s)
    Paracrestal implant placement
    Intervention Description
    Dental implants placed flush to the alveolar ridge
    Intervention Type
    Drug
    Intervention Name(s)
    prophylactic antibiotics
    Intervention Description
    amoxicillin was used before and after implant surgery for prophylactic reasons
    Intervention Type
    Device
    Intervention Name(s)
    dental implant
    Intervention Description
    dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge
    Intervention Type
    Radiation
    Intervention Name(s)
    x-ray examination
    Intervention Description
    radiographies were taken before treatment and at different time point during the follow-up period
    Primary Outcome Measure Information:
    Title
    Changes of marginal bone levels of dental implant
    Description
    Mesial and distal marginal bone level alterations at different time point compared with the base line. Marginal bone levels were measured with an image analysis software to the accuracy of 0.01 mm and the implant length is used as calibration for the measurement.
    Time Frame
    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
    Secondary Outcome Measure Information:
    Title
    Bleeding on probing(BOP)
    Description
    bleeding index whiling probing the implant restorations
    Time Frame
    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
    Title
    Probing pocket depth(PPD)
    Description
    probing depth of implant supported restorations
    Time Frame
    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)
    Title
    modified plaque index(PI)
    Description
    Modified plaque index to evaluate the oral hygiene conditions
    Time Frame
    3 months, 6 months, 1 year and 2 years post intervention (implant surgery)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: lose of two posterior teeth more than 3 months generally healthy (ASA score I) non-smoking periodontally healthy sufficient bone volume to place an implant without augmentation procedure Exclusion Criteria: medical and/or psychiatric contraindication to dental implant restoration local infection pregnancy or lactating poor oral hygiene tissue deficiency
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xi Jiang, DMD
    Organizational Affiliation
    Peking University school and hospital of stomotology, Department of oral implantology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Platform Switched Implant and Bone Level Alteration

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