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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsseoSpeed™
NobelSpeedy™ Replace®
NanoTite™ Certain® PREVAIL®
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Iowa, College of Dentistry
  • University of North Carolina, School of Dentistry
  • Perio Health Clinical Research Center
  • Faculty of Dentistry, McGill University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
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

Marginal Bone Level Alterations
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.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
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.
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
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.

Full Information

First Posted
January 9, 2009
Last Updated
April 24, 2020
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00820235
Brief Title
Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
Official Title
Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™
Intervention Description
OsseoSpeed™ implant
Intervention Type
Device
Intervention Name(s)
NobelSpeedy™ Replace®
Intervention Description
NobelSpeedy™ Replace® implant
Intervention Type
Device
Intervention Name(s)
NanoTite™ Certain® PREVAIL®
Intervention Description
NanoTite™ Certain® PREVAIL® implant
Primary Outcome Measure Information:
Title
Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
Description
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.
Time Frame
Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Secondary Outcome Measure Information:
Title
Marginal Bone Level Alterations
Description
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.
Time Frame
Evaluated at time of implant installation and at the 5-year follow-up visit.
Title
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Description
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.
Time Frame
Measured at time of loading of permanent restoration and at the 5-year follow-up.
Title
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
Description
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.
Time Frame
Measured at the implant loading and at the 5-year follow-up after loading.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Cooper, Prof.
Organizational Affiliation
University of Illinois College of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa, College of Dentistry
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1010
Country
United States
Facility Name
University of North Carolina, School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7450
Country
United States
Facility Name
Perio Health Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Faculty of Dentistry, McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2K6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25738335
Citation
McGuire MK, Scheyer T, Ho DK, Stanford CM, Feine JS, Cooper LF. Esthetic outcomes in relation to implant-abutment interface design following a standardized treatment protocol in a multicenter randomized controlled trial--a cohort of 12 cases at 1-year follow-up. Int J Periodontics Restorative Dent. 2015 Mar-Apr;35(2):149-59. doi: 10.11607/prd.2341.
Results Reference
result
PubMed Identifier
26009913
Citation
Cooper LF, Reside G, Stanford C, Barwacz C, Feine J, Abi Nader S, Scheyer ET, McGuire M. A multicenter randomized comparative trial of implants with different abutment interfaces to replace anterior maxillary single teeth. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):622-32. doi: 10.11607/jomi.3772.
Results Reference
result
PubMed Identifier
26096162
Citation
Barwacz CA, Stanford CM, Diehl UA, Qian F, Cooper LF, Feine J, McGuire M. Electronic assessment of peri-implant mucosal esthetics around three implant-abutment configurations: a randomized clinical trial. Clin Oral Implants Res. 2016 Jun;27(6):707-15. doi: 10.1111/clr.12640. Epub 2015 Jun 21.
Results Reference
result

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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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