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Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

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ClinicalTrials.gov Identifier: NCT00820235
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Study Description
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Brief Summary:
The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: OsseoSpeed™ Device: NobelSpeedy™ Replace® Device: NanoTite™ Certain® PREVAIL® Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
Actual Study Start Date : February 2009
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: A Device: OsseoSpeed™
OsseoSpeed™ implant
Active Comparator: B Device: NobelSpeedy™ Replace®
NobelSpeedy™ Replace® implant
Active Comparator: C Device: NanoTite™ Certain® PREVAIL®
NanoTite™ Certain® PREVAIL® implant


Outcome Measures
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Primary Outcome Measures :
  1. Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. [ Time Frame: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading ]

    Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading.

    The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.



Secondary Outcome Measures :
  1. Marginal Bone Level Alterations [ Time Frame: Evaluated at time of implant installation and at the 5-year follow-up visit. ]
    Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5-year follow-up visit compared to values obtained at time of implant placement.

  2. Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD [ Time Frame: Measured at time of loading of permanent restoration and at the 5-year follow-up. ]

    Condition of the periimplant mucosa by assessment of probing pocket depth (PPD).

    Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).

    Negative value = increased pocket depth.


  3. Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. [ Time Frame: Measured at the implant loading and at the 5-year follow-up after loading. ]
    Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent
  • At least 18 years
  • In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

  • Edentulous for at least 5 months at study site
  • A buccal-lingual bone width at study site of at least 5.5 mm
  • A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
  • A keratinized mid-buccal mucosal height of at least 2 mm at study site
  • Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss
  • Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
  • An opposing dentition with teeth, implants or prosthesis

Exclusion Criteria:

  • Insufficient interocclusal distance for implant placement and restoration at study site
  • Tooth adjacent (mesial and/or distal) to study site is ankylosed
  • More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
  • Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
  • Untreated rampant caries and/or uncontrolled periodontal disease
  • Class II division 2 malocclusion (Edward Hartley Angle)
  • Use of tobacco within last 6 months
  • Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
  • Current alcohol or drug abuse
  • Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Use of any substance that will influence bone metabolism
  • Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
  • History of radiation in the head and neck region
  • Known pregnancy, pregnancy tests will be performed as per local requirements.
  • Unable or unwilling to return for follow-up visits for a period of 5 years
  • Unlikely to be able to comply with study procedures according to Investigators judgement
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
  • Previous enrollment or randomization of treatment in the present study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820235


Locations
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United States, Iowa
University of Iowa, College of Dentistry
Iowa City, Iowa, United States, 52242-1010
United States, North Carolina
University of North Carolina, School of Dentistry
Chapel Hill, North Carolina, United States, 27599-7450
United States, Texas
Perio Health Clinical Research Center
Houston, Texas, United States, 77063
Canada, Quebec
Faculty of Dentistry, McGill University
Montreal, Quebec, Canada, H3A 2K6
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
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Study Director: Lyndon Cooper, Prof. University of Illinois College of Dentistry
More Information
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Publications of Results:

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Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00820235    
Other Study ID Numbers: YA-OSS-0003
First Posted: January 12, 2009    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases