CompletedNCT01389245Updated May 6, 2020Results posted

Study on OsseoSpeed™ TX Implants in the Upper Jaw in a Chinese Population

An interventional study of OsseoSpeed™ TX in Partially Edentulous Jaw, sponsored by Dentsply Sirona Implants and Consumables. Completed at 3 sites in China. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by Dentsply Sirona Implants and Consumables · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 42
Allocation: Not applicable
Ages: 20 Years to 75 Years
Sex: All

Study 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. Hypothesis: Early loading of the posterior maxilla is a safe and predictable procedure.

Conditions studied

Partially Edentulous Jaw

Browse trials for

Jaw, Edentulous 171

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 42 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Dentsply Sirona Implants and Consumables is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
OsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm
Device: OsseoSpeed™ TX

Interventions

DeviceOsseoSpeed™ TX
OsseoSpeed™ TX implants of lengths 8-17 mm

What researchers measure

Primary outcomes

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).
Time frame: Measured at implant loading and at the 3-year follow-up after implant loading.

Secondary outcomes

Number of Stable Implants
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at the 3-year follow-up after implant loading.

Results

Posted May 6, 2020

Participant flow

Participant flow — Overall Study
Milestone	OsseoSpeed™ TX
Started	42
Completed	27
Not completed	15
Withdrew: Protocol violation	10
Withdrew: Lost to follow-up	3
Withdrew: Withdrawal by subject	2

Outcome measures

PrimaryMarginal 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).

Time frame:: Measured at implant loading and at the 3-year follow-up after implant loading.
Reported as:: Mean · Millimeter

Marginal Bone Level Alteration
Millimeter	OsseoSpeed™ TX
Marginal Bone Level Alteration	-0.09 ± 0.83

SecondaryNumber of Stable Implants

Implant stability evaluated clinically/manually (recorded as stable yes/no).

Time frame:: Measured at the 3-year follow-up after implant loading.
Reported as:: Count of units · Implants

Number of Stable Implants
Implants	OsseoSpeed™ TX
Number of Stable Implants	86

SecondaryEvaluation 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.

Time frame:: Measured at the 3-year follow-up after implant loading.
Reported as:: Mean · Millimeter

Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Millimeter	OsseoSpeed™ TX
Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD	-0.23 ± 0.90

SecondaryNumber of Survived Implants

Implant survival rate evaluated by clinically and radiographically, counting the number of implants remaining in function.

Time frame:: Measured at the 3-year follow-up after implant loading.
Reported as:: Count of units · Implants

Number of Survived Implants
Implants	OsseoSpeed™ TX
Number of Survived Implants	103

SecondaryPresence 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.

Time frame:: Measured at the 3-year follow-up after implant loading.
Reported as:: Count of units · Implants

Presence of Plaque
Implants	OsseoSpeed™ TX
Presence of Plaque	9

Adverse events

Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OsseoSpeed™ TX	—	3/42 (7.1%)	7/42 (16.7%)

Most frequent serious events

Most frequent serious events
Event	OsseoSpeed™ TX
Paralytic strokeVascular disorders	1/42
Adenocarcinoma of urinary bladderRenal and urinary disorders	1/42
Femur Neck FractureMusculoskeletal and connective tissue disorders	1/42

Most frequent other events

Most frequent other events
Event	OsseoSpeed™ TX
Insufficient osseointegration of the implant during healing phaseMusculoskeletal and connective tissue disorders	7/42

Baseline characteristics

Baseline analysis population = Per Protocol Population. I.e. Protocol deviators excluded, a total of 10 subjects with 24 implants.

Age, Continuous
Age, Continuous(Years)	OsseoSpeed™ TX
Mean	56.0 ± 11.3

Sex: Female, Male
Sex: Female, Male(Participants)	OsseoSpeed™ TX
Female	14
Male	18

Region of Enrollment
Region of Enrollment(Participants)	OsseoSpeed™ TX
China	32

Study locations

3 sites

Capital Medical University School of Stomatology, Centre of Oral Implantation
Beijing, 100050, China
Guanghua School of Stomatology, Sun Yat-Sen University
Guangzhou, 510055, China
Department of Prosthodontics, Nanjing Stomatology Hospital, Nanjing University
Nanjing, 210008, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01389245
Lead sponsor: Dentsply Sirona Implants and Consumables
Responsible party: Sponsor
First posted: Jul 8, 2011
Start date: Jun 2011
Primary completion: Jul 2015
Completion: Sep 2017
Results posted: May 6, 2020
Last update: May 6, 2020

Study contacts

Deng Feilong, MD

principal investigator · Guanghua School of Stomatology, Sun Yat-Sen University, Guangzhou

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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