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The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability

Primary Purpose

Partial Edentulism, Tooth Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short implants Treatment
Regular implants Treatment
Sponsored by
Jakub Hadzik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Edentulism focused on measuring implant, dental implant

Eligibility Criteria

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

Inclusion Criteria:

  • Non-smoking patients with no systemic or local diseases were qualified.

Additional inclusion criteria were as follows:

  • minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification
  • minimal width of the alveolar ridge of 6-7 mm in the region of interest
  • HKT (height of the keratinized tissue) higher than 2 mm
  • API ≤ 35 (Approximal Plaque Index)
  • PI ≤ 25. (Plaque Index)
  • Bone Type III or D2 were included in the study
  • No graft procedures in the area of interest,

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Short implants Treatment

    Regular Implants Treatment

    Arm Description

    Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure.

    Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon.

    Outcomes

    Primary Outcome Measures

    Clinical measurement of implant stability
    Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.

    Secondary Outcome Measures

    Radiological measurement of marginal bone loss around implant
    Evalation if there is difference in marginal bone level around the implants in both groups. Periapical radiographs and CBCT images taken and the begining and at the end of the observation period will be compared and bone level will be measured. Loss of marginal bone will be calculated.

    Full Information

    First Posted
    March 5, 2018
    Last Updated
    January 11, 2020
    Sponsor
    Jakub Hadzik
    Collaborators
    Dentsply Sirona Implants and Consumables, Wrocław Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03471000
    Brief Title
    The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability
    Official Title
    The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability - 36 Months Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2012 (Actual)
    Primary Completion Date
    January 1, 2016 (Actual)
    Study Completion Date
    January 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jakub Hadzik
    Collaborators
    Dentsply Sirona Implants and Consumables, Wrocław Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the study was to determine whether implant length and the crown-to-implant (C/I) ratio influence implant stability and the loss of the surrounding marginal bone, and whether short implants can be used instead of sinus augmentation procedures.
    Detailed Description
    The patients participating in the study (n=30) had one single tooth implant - a short (OsseoSpeed™ L6Ø4 mm, Implants) or a regular implant (OsseoSpeed™ L11 and L13Ø4 mm, DENTSPLY Implants) - placed in the maxilla. The evaluation was based on clinical and radiological examination. The crown-to-implant ratio was determined by dividing the length of the crown together with the abutment by the length of the implant placed crestally. Mean crown-to-implant ratios were calculated separately for each group and its correlation with the MBL (marginal bone loss) and stability was assessed. The authors compared the correlation between the C/I ratio values, MBL and secondary implant stability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Partial Edentulism, Tooth Loss
    Keywords
    implant, dental implant

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Short implants Treatment
    Arm Type
    Experimental
    Arm Description
    Group 2 (G2; n=15 patients) had short implants (OsseoSpeed ™ L6mm Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed without sinus lift and augmentation procedure.
    Arm Title
    Regular Implants Treatment
    Arm Type
    Active Comparator
    Arm Description
    Group 1 (G1; n=15 patients) had conventional dental implants (OsseoSpeed ™ L11 Ø4 mm and L13 Ø4 mm) [DENTSPLY Implants, Waltham, MA, USA] placed, preceded by the sinus lift procedure from a lateral window approach with the application of the xenogeneic bone graft Geistlich Bio-Oss® [Geistlich AG, Wolhusen, Switzerland]. The lateral window approach sinus lift surgery was performed 6 weeks prior to the implant placement by the same surgeon.
    Intervention Type
    Other
    Intervention Name(s)
    Short implants Treatment
    Intervention Description
    Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
    Intervention Type
    Other
    Intervention Name(s)
    Regular implants Treatment
    Intervention Description
    Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
    Primary Outcome Measure Information:
    Title
    Clinical measurement of implant stability
    Description
    Evaluation of implant secondary stability in both groups. Stability measured and evaluated with Periotest(R) device - after 36 months.
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Radiological measurement of marginal bone loss around implant
    Description
    Evalation if there is difference in marginal bone level around the implants in both groups. Periapical radiographs and CBCT images taken and the begining and at the end of the observation period will be compared and bone level will be measured. Loss of marginal bone will be calculated.
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-smoking patients with no systemic or local diseases were qualified. Additional inclusion criteria were as follows: minimal apicocoronal height of the alveolar ridge of 6 mm in the region of the implant insertion in the pre-surgical qualification minimal width of the alveolar ridge of 6-7 mm in the region of interest HKT (height of the keratinized tissue) higher than 2 mm API ≤ 35 (Approximal Plaque Index) PI ≤ 25. (Plaque Index) Bone Type III or D2 were included in the study No graft procedures in the area of interest, Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marzena Dominiak, Prof
    Organizational Affiliation
    Medical University Wrocław
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29862269
    Citation
    Hadzik J, Krawiec M, Slawecki K, Kunert-Keil C, Dominiak M, Gedrange T. The Influence of the Crown-Implant Ratio on the Crestal Bone Level and Implant Secondary Stability: 36-Month Clinical Study. Biomed Res Int. 2018 May 16;2018:4246874. doi: 10.1155/2018/4246874. eCollection 2018.
    Results Reference
    result

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    The Influence of the Crown-implant Ratio on the Crestal Bone Level and Implant Secondary Stability

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