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

April 24, 2020 updated by: Dentsply Sirona Implants

Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 2K6
        • Faculty of Dentistry, McGill University
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242-1010
        • University of Iowa, College of Dentistry
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7450
        • University of North Carolina, School of Dentistry
    • Texas
      • Houston, Texas, United States, 77063
        • Perio Health Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Evaluated at time of implant installation and at the 5-year follow-up visit.
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.
Measured at time of loading of permanent restoration and at the 5-year follow-up.
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.
Measured at the implant loading and at the 5-year follow-up after loading.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dentsply Sirona Implants

Investigators

  • Study Director: Lyndon Cooper, Prof., University of Illinois College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2009

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (ESTIMATE)

January 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YA-OSS-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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