Partially Edentulous JawNCT01346696
Study on OsseoSpeed™ TX Short Implants in a Chinese Population
A study testing OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) 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 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and 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 implant (Ø 4.0 mm, length 6 mm)
- 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
- Feb 2011to Mar 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
- Female and male aged 20-75 years at enrolment
- In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
- Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 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
- 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
Show all 15Show fewer
- 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 enrolment 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
Department of Periodontology, School of Stomatology, Peking University
Beijing, 100081
Department of Implantology, School of Stomatology, Peking University
Beijing
Second Dental and Periodontal Center, School of Stomatology, Peking University
Beijing
About this study
Official title: An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
- Conditions
- Partially Edentulous Jaw
- Being tested
- OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)
- 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™ TX implant (Ø 4.0 mm, length 6 mm)Device
| Study group | Role | What they receive |
|---|---|---|
| OsseoSpeed™ TX implants | Experimental | OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. Receives: Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) |
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 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading.
Positive value = bone gain, Negative values = bone loss.
Measured: Evaluated from implant installation to 12 months after implant loading
Secondary outcomes (7)
Marginal Bone Level Alteration After 36 Months
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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading.
Positive value = bone gain, Negative values = bone loss.
Measured: Evaluated from implant loading to 36 months after implant loading.
Implant Survival
Implant survival rate evaluated clinically and radiographically.
Measured: Evaluated from implant installation to 36 months after implant loading.
Implant Stability
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Measured: Evaluated 36 months after implant loading.
Condition of the Periimplant Mucosa (PPD).
Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD).
Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Negative value = increased pocket depth
Measured: Evaluated from implant loading to 36 months after implant loading.
Condition of the Periimplant Mucosa (BoP).
Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP).
Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.
Measured: Evaluated from implant loading to 36 months after implant loading.
Plaque
Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
Measured: Evaluated 36 months after implant loading.
Crown-to-implant Ratio
Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs
Measured: 12 months 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 posted3 May 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2016
- Study completionMar 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 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
- Huan Xin Meng, Prof, Principal investigator, Department of Periodontology, School of Stomatology, Beijing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346696
- Sponsor's protocol ID
- CHN-0005
- Status last verified
- Oct 2019
- First submitted
- 2 May 2011
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed() TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. doi: 10.1111/clr.12587. Epub 2015 Apr 9.
PubMed 25855871Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 Dec 8.
PubMed 29218810Wei D, Sui H, Zhang H, Tang Z, Zhang X, Meng H, Han J. Long-Term Outcomes of 6-mm Short Implants Supporting Splinted Crowns in Posterior Regions: A 12-Year Prospective Multi-Centre Single-Cohort Study. J Clin Periodontol. 2026 Aug;53(8):1278-1288. doi: 10.1111/jcpe.70144. Epub 2026 May 26.
PubMed 42192196
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.
- ClinicalTrials.gov ID
- NCT01346696
- Acronym / sponsor ID
- CHN-0005
- 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
- Feb 2011 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 10 May 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 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.
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 implants | Experimental | Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent
- Female and male aged 20-75 years at enrolment
- In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
Key exclusion criteria (15 listed)
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
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™ TX implant (Ø 4.0 mm, length 6 mm) | Device | OsseoSpeed™ TX implants |
Primary outcome
Marginal Bone Level Alteration
Time frame: Evaluated from implant installation to 12 months after implant loading
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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss.
7 secondary outcomes
Marginal Bone Level Alteration After 36 Months
Time frame: Evaluated from implant loading to 36 months after implant loading.
Implant Survival
Time frame: Evaluated from implant installation to 36 months after implant loading.
Implant Stability
Time frame: Evaluated 36 months after implant loading.
Condition of the Periimplant Mucosa (PPD).
Time frame: Evaluated from implant loading to 36 months after implant loading.
Condition of the Periimplant Mucosa (BoP).
Time frame: Evaluated from implant loading to 36 months after implant loading.
Plaque
Time frame: Evaluated 36 months after implant loading.
Crown-to-implant Ratio
Time frame: 12 months after implant loading
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25855871Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed() TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. doi: 10.1111/clr.12587. Epub 2015 Apr 9.
- Results publication: PubMed 29218810Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 Dec 8.
- Derived from this study: PubMed 42192196Wei D, Sui H, Zhang H, Tang Z, Zhang X, Meng H, Han J. Long-Term Outcomes of 6-mm Short Implants Supporting Splinted Crowns in Posterior Regions: A 12-Year Prospective Multi-Centre Single-Cohort Study. J Clin Periodontol. 2026 Aug;53(8):1278-1288. doi: 10.1111/jcpe.70144. Epub 2026 May 26.
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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.
Huan Xin Meng, Prof principal investigator
Department of Periodontology, School of Stomatology, Beijing 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 implant (Ø 4.0 mm, length 6 mm) 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 8 inclusion and 15 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 8 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 10 May 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?
Marginal Bone Level Alteration (time frame: Evaluated from implant installation to 12 months after implant 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 NCT01346696, 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 8 Oct 2019.