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Completed

NCT Number: NCT01389245

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

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.

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Key information

Conditions

Partially Edentulous Jaw Jaw Diseases Jaw, Edentulous Jaw, Edentulous, Partially Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University School of Stomatology, Centre of Oral Implantation, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

OsseoSpeed™ TX

Device

OsseoSpeed™ TX implants of lengths 8-17 mm

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of Stable Implants

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

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

  2. Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD

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

    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.

  3. 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.

  4. Presence of Plaque

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

    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.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jul 8, 2011
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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