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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234584
First Posted: November 4, 2010
Last Update Posted: December 8, 2010
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.
Information provided by:
Rambam Health Care Campus
  Purpose
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.

Condition Intervention
Group A- 23 Implant Using Switch Platform -SPK Abutment. Group B- 22 Implant Using the Traditional -CPK Abutment. Procedure: spk Procedure: CPK Abutments

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
23 implants using SPK Abutments
Procedure: spk
implants using SPK Abutments
Active Comparator: Group B
implants using CPK Abutments
Procedure: CPK Abutments
implants using CPK Abutments

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234584


Locations
Israel
Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus Recruiting
Haifa, Israel
Contact: Zvi Gutmacher, DMD    +97252-5777636    dr_zviu3@netvision.net.il   
Sub-Investigator: Eli Machtei, DMD         
Sub-Investigator: Israel Blumenfeld, DMD         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Dr. zvi Gutmacher, Department of Maxillofacial Rehabilitation School of Gradute Dentistry Rambam Health care campus Haifa, Israel
ClinicalTrials.gov Identifier: NCT01234584     History of Changes
Other Study ID Numbers: CTIL0227-10-RMB
First Submitted: November 3, 2010
First Posted: November 4, 2010
Last Update Posted: December 8, 2010
Last Verified: September 2010


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