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OpenTrials
Completed

NCT Number: NCT01346696

Study on OsseoSpeed™ TX Short Implants in a Chinese Population

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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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

Department of Implantology, School of Stomatology, Peking University, 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Marginal Bone Level Alteration After 36 Months

    Time frame: Evaluated from implant loading to 36 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 36 months after loading.

    Positive value = bone gain, Negative values = bone loss.

  2. Implant Survival

    Time frame: Evaluated from implant installation to 36 months after implant loading.

    Implant survival rate evaluated clinically and radiographically.

  3. Implant Stability

    Time frame: Evaluated 36 months after implant loading.

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

  4. Condition of the Periimplant Mucosa (PPD).

    Time frame: Evaluated from implant loading to 36 months after implant loading.

    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

  5. Condition of the Periimplant Mucosa (BoP).

    Time frame: Evaluated from implant loading to 36 months after implant loading.

    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.

  6. Plaque

    Time frame: Evaluated 36 months after implant loading.

    Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.

  7. Crown-to-implant Ratio

    Time frame: 12 months after implant loading

    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

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 3, 2011
Registry last updated
Oct 8, 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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