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Completed

NCT Number: NCT01340170

A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

This study is initiated to support the OsseoSpeedTM TX implant with clinical data showing that a soft bone drilling protocol and immediate loading does not have any important negative effect on marginal bone level maintenance.

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Key information

Conditions

Edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio Associato Maffei, Bari, Italy

Loading trial locations.

About this study

This study is designed to evaluate a soft bone drilling protocol compared to a standard bone drilling protocol when using OsseoSpeedTM TX with regards to marginal bone level changes and implant survival rate one year after loading. The aim is also to investigate potential differences in initial stability and in general user friendliness between the two drilling protocols.

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/male aged 18 years and over
  • History of edentulism in the study area of at least 3 months
  • At least 4 months healing after last grafting procedure in the study area
  • In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47
  • The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition.
  • Deemed by the investigator to be suitable for one stage surgery
  • Deemed by the investigator to be suitable for immediate loading
  • Deemed by the investigator as likely to present an initially stable implant situation.
  • Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion criteria

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Uncontrolled pathological 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 would compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Present alcohol and/or drug abuse
  • Current need for bone grafting and/or augmentation in the planned implant area
  • 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.

Treatment and study plan

OsseoSpeed TX

Device

OsseoSpeed TX dental implants, 6-17 mm

Primary outcomes

  1. Marginal Bone Level Change

    Time frame: Implant insertion and 12 months post implant insertion

    Marginal Bone Level alterations will be 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.

Secondary outcomes

  1. Marginal Bone Level Change

    Time frame: Implant insertion and 3 months post implant insertion

    Marginal Bone Level alterations will be 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.

  2. Implant Survival Rate

    Time frame: 12 months after baseline, i.e., implant insertion

    Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.

  3. Implant Stability Assessed Clinically/Manually

    Time frame: At implant insertion

    Evaluated clinically/manually and recorded as stable yes/no.

  4. Implant Stability Using Resonance Frequency Analysis (RFA)

    Time frame: At implant insertion.

    The Osstell® instrument "Osstell® ISQ" will be used to measure RFA. RFA measures the frequency with which a device vibrates. By comparing resonance frequencies the stability of a dental implant can be determined as the resonance frequency changes with different stability. The Osstell® ISQ instrument translates the RFA value into an Implant Stability Quotient (ISQ) scale value. ISQ is a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro mobility, with a higher value corresponding to increased stability.

  5. Perception During Implant Insertion - "The Implant Was Guided Into the Prepared Osteotomy"

    Time frame: After implant insertion

    After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

  6. Perception During Implant Insertion - "The Implant Followed the Prepared Osteotomy"

    Time frame: After implant insertion

    After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

  7. Perception During Implant Insertion - "The Implant Has a Good Primary Stability"

    Time frame: After implant insertion

    After implant insertion, a questionnaire will be completed for each study implant by the surgeon. The questionnaire contains following statements "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy" and "The implant has a good primary stability". The surgeon records his/her response to each statement with a number from 1 to 10 , where 1= totally disagree with the statement, and 10= totally agree with the statement.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Non-randomized, Prospective Multi-centre Study Evaluating a Soft Bone Drilling Protocol for Single Tooth Restoration in the Posterior Area With Immediate Loading

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2011
Registry last updated
Nov 15, 2024

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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