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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 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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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.



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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 3, 2010
Last Updated: December 7, 2010
Health Authority: Israel: IRB

ClinicalTrials.gov processed this record on November 20, 2014