Partially Edentulous JawNCT01473355
Study on OsseoSpeed™ TX Narrow Implants in the Lower 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 mandible 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
- Oct 2011to Oct 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 enrolment
- History of edentulism in the study area of at least two months
- 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
School of Stomatology, JiLin University, Hospital of Stomatology
Changchun
Sichuan University
Chengdu, 610041
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, 310003
About this study
Official title: An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. 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 mandible 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) in lengths of 11-15 mm Receives: Device: OsseoSpeed™ TX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Survived Implants
Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function
Measured: Measured at the 3 year follow-up after implant loading.
Secondary outcomes (5)
Marginal Bone Level Alteration
Marginal bone level determined from radiographs and expressed as the distance 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 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Measured: Measured at the 3 year follow-up after implant loading.
Number of Stable Implants
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Measured: Measured at the 3 year follow-up after implant loading.
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 3-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 the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of 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 the 3 year follow-up after implant loading.
Presence of Plaque
Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.
Measured: Measured at the 3 year follow-up after implant loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2014
- Study completionOct 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
- Ping Gong, Prof, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473355
- Sponsor's protocol ID
- CHN-0003
- Status last verified
- Oct 2019
- First submitted
- 15 Nov 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 Mandible. A 3-years Follow-up Study.
- ClinicalTrials.gov ID
- NCT01473355
- Acronym / sponsor ID
- CHN-0003
- 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
- Oct 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Posted 7 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 mandible 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) in lengths of 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 (6 listed)
- Provision of informed consent
- Aged 20-75 years at enrolment
- History of edentulism in the study area of at least two months
- 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
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
Number of Survived Implants
Time frame: Measured at the 3 year follow-up after implant loading.
Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function
5 secondary outcomes
Marginal Bone Level Alteration
Time frame: Measured at the 3 year follow-up after implant loading.
Number of Stable Implants
Time frame: Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Time frame: Measured at the 3 year follow-up after implant loading.
Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP
Time frame: Measured at the 3 year follow-up after implant loading.
Presence of Plaque
Time frame: Measured at the 3 year follow-up after implant 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.
Ping Gong, Prof principal investigator
Sichuan University
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 6 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 7 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?
Number of Survived Implants (time frame: Measured at the 3 year follow-up 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; AzTrials last refreshed its copy on 27 Oct 2026.