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Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234584
Recruitment Status : Unknown
Verified September 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : November 4, 2010
Last Update Posted : December 8, 2010
Information provided by:
Rambam Health Care Campus

November 3, 2010
November 4, 2010
December 8, 2010
September 2010
June 2011   (Final data collection date for primary outcome measure)
  • Soft tissue evaluation: [ Time Frame: 12 month ]
    Three month following abutment connection (approximately 2 months following cementation of the final crowns) baseline measurement will be taken. This will include probing pockets depth (PPD) and bleeding on probing (BOP) dichotomized in to 0 and 1 This measurement will be repeated at 12 month post surgery.
  • Radiographic evaluation: [ Time Frame: 12 month post surgery ]

    Bite wing radiographs will be used to assess changes in radiographic bone height.

    Baseline radiographs will be taking immediately following abutment connection and final radiographic evaluation will be taken 12 months post surgery.

Same as current
Complete list of historical versions of study NCT01234584 on Archive Site
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Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
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The purpose of this present study is to compare alveolar bone changes and markers of gingival health around the new Lanes® dental implant which were rehabilitate using the new switch platform abutment ( SPR ) and the traditional ( CPK ) abutment.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Group A- 23 Implant Using Switch Platform -SPK Abutment.
  • Group B- 22 Implant Using the Traditional -CPK Abutment.
  • Procedure: spk
    implants using SPK Abutments
  • Procedure: CPK Abutments
    implants using CPK Abutments
  • Experimental: Group A
    23 implants using SPK Abutments
    Intervention: Procedure: spk
  • Active Comparator: Group B
    implants using CPK Abutments
    Intervention: Procedure: CPK Abutments
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult patient aged 18 - 80 yrs.
  2. Implants treatment planned for single crown rehabilitation.
  3. Submerged implant placement.
  4. Patients willing to participate in a twelve month study.
  5. Up to 2 implants per patient will be allowed.

Exclusion Criteria:

  1. Active periodontal disease.
  2. Systemic condition and medication that may affect soft and hard tissue healing.
  3. Pregnancy or intention to become pregnant in the next twelve months.
  4. Parafunctional occlusal scheme and habits.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Dr. zvi Gutmacher, Department of Maxillofacial Rehabilitation School of Gradute Dentistry Rambam Health care campus Haifa, Israel
Rambam Health Care Campus
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Rambam Health Care Campus
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP