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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Rambam Health Care Campus

Brief Summary:
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 or disease Intervention/treatment Phase
Group A- 23 Implant Using Switch Platform -SPK Abutment. Group B- 22 Implant Using the Traditional -CPK Abutment. Procedure: spk Procedure: CPK Abutments Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : September 2010
Estimated Primary Completion Date : June 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.




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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.

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

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 Posted: November 4, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: September 2010