Partially Edentulous JawNCT01389258
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population
A study testing OsseoSpeed™ TX in people with Partially Edentulous Jaw, run by Dentsply Sirona Implants and Consumables at 3 sites in China.
Trial summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Partially Edentulous Jaw
- What is being tested?
- OsseoSpeed™ TX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2011to Aug 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Aged 20-75 years at enrollment
- History of edentulism in the study area of at least two months
- Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- Deemed by the investigator as likely to present an initially stable implant situation
Who cannot join
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
Show all 13Show fewer
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrollment in the present study
- Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Trial locations and contacts
3 sites in 1 country.
China3 sites
Tong Ji University, Oral Implants Department
Shanghai
School of Stomatology Wuhan University
Wuhan, 430079
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University
Xi'an, 710032
About this study
Official title: An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
- Conditions
- Partially Edentulous Jaw
- Being tested
- OsseoSpeed™ TX
- 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™ TXDevice
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
| Study group | Role | What they receive |
|---|---|---|
| OsseoSpeed™ TX | Experimental | OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm Receives: Device: OsseoSpeed™ TX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Measured: Measured at the 3-year follow-up visit after implant loading.
Secondary outcomes (6)
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Measured: Measured at the 3-year follow-up visit after implant loading.
Marginal Bone Level Alteration
Marginal Bone Level (mm) determined from radiographs and expressed as a 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 obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).
Measured: Measured at the 3-year follow-up visit after implant loading.
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).
Negative value = increased pocket depth.
Measured: Measured at implant loading and at the 3-year follow-up visit after loading.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.
Measured: Measured at implant loading and at the 3-year follow-up visit after loading.
Presence of Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.
Measured: Measured at the 3-year follow-up visit after implant loading.
Gingival Zenith Score
Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.
Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.
Measured: Measured at implant loading and at the 3-year follow-up visit after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionAug 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.
- Other trials for Partially Edentulous JawStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Dehua, Prof, Principal investigator, Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389258
- Sponsor's protocol ID
- CHN-0006
- Status last verified
- Oct 2019
- First submitted
- 6 Jul 2011
- Last updated
- 15 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.
- ClinicalTrials.gov ID
- NCT01389258
- Acronym / sponsor ID
- CHN-0006
- Conditions
- Partially Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OsseoSpeed™ TX | Experimental | Device: OsseoSpeed™ TXOsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Aged 20-75 years at enrollment
- History of edentulism in the study area of at least two months
- Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
Key exclusion criteria (13 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
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™ TXOsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm | Device | OsseoSpeed™ TX |
Primary outcome
Implant Survival
Time frame: Measured at the 3-year follow-up visit after implant loading.
Implant survival rate evaluated clinically and radiographically.
6 secondary outcomes
Implant Stability
Time frame: Measured at the 3-year follow-up visit after implant loading.
Marginal Bone Level Alteration
Time frame: Measured at the 3-year follow-up visit after implant loading.
Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.
Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.
Presence of Plaque
Time frame: Measured at the 3-year follow-up visit after implant loading.
Gingival Zenith Score
Time frame: Measured at implant loading and at the 3-year follow-up visit after loading.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Li Dehua, Prof principal investigator
Dept. of Oral Implants, School of Stomatology, Fourth Military Medical University, Xi'an
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoSpeed™ TX in people with Partially Edentulous Jaw, run by Dentsply Sirona Implants and Consumables at 3 sites in China.
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 7 inclusion and 13 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 8 Oct 2019). 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?
Implant Survival (time frame: Measured at the 3-year follow-up visit after implant loading.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2019.