Partially Edentulous JawNCT01389245
Study on OsseoSpeed™ TX 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 implants 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
- 42 participants
- Where
- 3 sitesChina
- Study dates
- Jun 2011to Sep 2017
- 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 posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
- Neighboring tooth to the planned bridge must have natural root.
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
- 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
- Earlier graft procedures in the study area
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
Show all 16Show fewer
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/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 6 months.
- Subjects that are unable to give informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites
Capital Medical University School of Stomatology, Centre of Oral Implantation
Beijing, 100050
Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, 510055
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Nanjing, 210008
About this study
Official title: An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior maxilla 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 implants of lengths 8-17 mm
| Study group | Role | What they receive |
|---|---|---|
| OsseoSpeed™ TX | Experimental | OsseoSpeed™ TX implants of lengths 8-17 mm Receives: Device: OsseoSpeed™ TX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 implant loading and at the 3-year follow-up after implant loading.
Secondary outcomes (4)
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.
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.
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-year 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 posted8 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2015
- Study completionSep 2017
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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deng Feilong, MD, Principal investigator, Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389245
- Sponsor's protocol ID
- CHN-0001
- Status last verified
- Apr 2020
- First submitted
- 6 Jul 2011
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
- ClinicalTrials.gov ID
- NCT01389245
- Acronym / sponsor ID
- CHN-0001
- Conditions
- Partially Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Posted 6 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 purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior maxilla 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 implants of lengths 8-17 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 posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
- Neighboring tooth to the planned bridge must have natural root.
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
Key exclusion criteria (16 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
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 implants of lengths 8-17 mm | Device | OsseoSpeed™ TX |
Primary outcome
Marginal Bone Level Alteration
Time frame: Measured at implant loading and at the 3-year follow-up after implant loading.
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).
4 secondary outcomes
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.
Number of Survived Implants
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 6 May 2020.
- 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.
Deng Feilong, MD principal investigator
Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou
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 16 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 6 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 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 6 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?
Marginal Bone Level Alteration (time frame: Measured at implant loading and 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 6 May 2020.