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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsseoSpeed™ TX implants | Experimental | OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated from implant installation to 12 months after implant loading |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huan Xin Meng, Prof | Department of Periodontology, School of Stomatology, Beijing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, School of Stomatology, Peking University | Beijing | 100081 | China | |||
| Department of Implantology, School of Stomatology, Peking University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25855871 | Result | 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. | |
| 29218810 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | OsseoSpeed™ TX Implants | OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OsseoSpeed™ TX Implants | OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Six of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (69 implants) as basis for the 12 months analysis of MBL change. | Posted | Mean | Standard Deviation | millimeter | Evaluated from implant installation to 12 months after implant loading | Implants | Implants |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OsseoSpeed™ TX Implants | OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right femoral neck fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study implant not stable - implant lost | Investigations | Non-systematic Assessment | 4 subjects lost one of their implants due to insufficient osseointegration. Those were all lost during the healing phase, before loading of the implant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| Evaluated from implant loading to 36 months after implant loading. |
| Implant Survival | Implant survival rate evaluated clinically and radiographically. | Evaluated from implant installation to 36 months after implant loading. |
| Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no). | 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 | 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. | 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. | 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 | 12 months after implant loading |
| Beijing |
| China |
| Second Dental and Periodontal Center, School of Stomatology, Peking University | Beijing | China |
| Han 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. |
| 42192196 | Derived | Wei 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 May 26. doi: 10.1111/jcpe.70144. Online ahead of print. |
| Implants |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| OsseoSpeed™ TX Implants |
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. |
|
|
| Secondary | 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. | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Four of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (71 implants) as basis for the 36 months analysis. | Posted | Mean | Standard Deviation | millimeter | Evaluated from implant loading to 36 months after implant loading. |
|
|
|
| Secondary | Implant Survival | Implant survival rate evaluated clinically and radiographically. | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). | Posted | Count of Units | Implants | Evaluated from implant installation to 36 months after implant loading. | Implants | Implants |
|
|
|
| Secondary | Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no). | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). | Posted | Count of Units | Implants | Evaluated 36 months after implant loading. | Implants | Implants |
|
|
|
| Secondary | 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 | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Baseline and/or follow-up measurements not available for 3 implants, giving an overall number of 36 subjects (72 implants) as basis for the 36 months analysis of PPD change. | Posted | Mean | Standard Deviation | millimeter | Evaluated from implant loading to 36 months after implant loading. | Implants | Implants |
|
|
|
| Secondary | 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. | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). The BoP measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of BoP. | Posted | Count of Units | Implants | Evaluated from implant loading to 36 months after implant loading. | Implants | Implants |
|
|
|
| Secondary | 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. | 44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). Plaque measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of Plaque. | Posted | Count of Units | Implants | Evaluated 36 months after implant loading. | Implants | Implants |
|
|
|
| Secondary | 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 | 45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants). 6 of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (68 implants) as basis for 12 months analysis of Crown-to-implant ratio. | Posted | Mean | Standard Deviation | Ratio | 12 months after implant loading | Implants | Implants |
|
|
|
| 3 |
| 45 |
| 6 |
| 45 |
| Hepatic hilum cholangiocarcinoma | Hepatobiliary disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
|
| Study implant not stable - extended healing time | Investigations | Systematic Assessment | 3 subjects had implants that required extended healing time in order to achieve stability. |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |