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OpenTrials
Completed

NCT Number: NCT01389258

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

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant 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 3 mm implant 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

Tong Ji University, Oral Implants Department, Shanghai, 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 study area of at least two months
  • Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
  • Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
  • Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
  • 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
  • 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, as deemed by the investigator
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes per 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 weeks prior to enrollment

Treatment and study plan

OsseoSpeed™ TX

Device

OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm

Primary outcomes

  1. Implant Survival

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

    Implant survival rate evaluated clinically and radiographically.

Secondary outcomes

  1. Implant Stability

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

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

  2. Marginal Bone Level Alteration

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

    Marginal Bone Level (mm) determined from radiographs and expressed as a 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.

    Marginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline).

  3. Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).

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

    Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).

    Negative value = increased pocket depth.

  4. Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).

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

    Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.

  5. Presence of Plaque

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

    Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.

  6. Gingival Zenith Score

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

    Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.

    Presented as change from loading of permanent restoration to time of the 3-year follow-up visit.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Jul 8, 2011
Registry last updated
Oct 15, 2019

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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