Jaw, Edentulous, PartiallyNCT00820235
Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw
A study testing OsseoSpeed™, NobelSpeedy™ Replace® and NanoTite™ Certain® PREVAIL® in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- OsseoSpeed™, NobelSpeedy™ Replace® and NanoTite™ Certain® PREVAIL®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2009to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of North Carolina, School of Dentistry
Chapel Hill, North Carolina, 27599-7450
Perio Health Clinical Research Center
Houston, Texas, 77063
University of Iowa, College of Dentistry
Iowa City, Iowa, 52242-1010
About this study
Official title: 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.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- OsseoSpeed™, NobelSpeedy™ Replace®, NanoTite™ Certain® PREVAIL®
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoSpeed™Device
OsseoSpeed™ implant
NobelSpeedy™ Replace®Device
NobelSpeedy™ Replace® implant
NanoTite™ Certain® PREVAIL®Device
NanoTite™ Certain® PREVAIL® implant
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: OsseoSpeed™ |
| B | Active comparator | Not described Receives: Device: NobelSpeedy™ Replace® |
| C | Active comparator | Not described Receives: Device: NanoTite™ Certain® PREVAIL® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Secondary outcomes (3)
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.
Measured: Evaluated at time of implant installation and at the 5-year follow-up visit.
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.
Measured: 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.
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: Measured at the implant loading and at the 5-year follow-up after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lyndon Cooper, Prof., Study director, University of Illinois College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820235
- Sponsor's protocol ID
- YA-OSS-0003
- Status last verified
- Apr 2020
- First submitted
- 9 Jan 2009
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25738335Cooper 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.
PubMed 26009913Barwacz 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.
PubMed 26096162
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
- ClinicalTrials.gov ID
- NCT00820235
- Acronym / sponsor ID
- YA-OSS-0003
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Posted 7 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: OsseoSpeed™ |
| B | Active comparator | Device: NobelSpeedy™ Replace® |
| C | Active comparator | Device: NanoTite™ Certain® PREVAIL® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsseoSpeed™OsseoSpeed™ implant | Device | A |
| NobelSpeedy™ Replace®NobelSpeedy™ Replace® implant | Device | B |
| NanoTite™ Certain® PREVAIL®NanoTite™ Certain® PREVAIL® implant | Device | C |
Primary outcome
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.
3 secondary outcomes
Marginal Bone Level Alterations
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25738335McGuire 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 publication: PubMed 26009913Cooper 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 publication: PubMed 26096162Barwacz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Cooper, Prof. study director
University of Illinois College of Dentistry
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed™, NobelSpeedy™ Replace® and NanoTite™ Certain® PREVAIL® in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.