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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01234584
First received: November 3, 2010
Last updated: December 7, 2010
Last verified: September 2010

November 3, 2010
December 7, 2010
September 2010
June 2011   (final data collection date for primary outcome measure)
  • Soft tissue evaluation: [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
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.
Both
18 Years to 80 Years
Yes
Israel
 
NCT01234584
CTIL0227-10-RMB
Not Provided
Dr. zvi Gutmacher, Department of Maxillofacial Rehabilitation School of Gradute Dentistry Rambam Health care campus Haifa, Israel
Rambam Health Care Campus
Not Provided
Not Provided
Rambam Health Care Campus
September 2010

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