- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01234584
Soft and Hard Tissue Changes Around the New Lance® Implants Using Traditional and Switch Platform Abutments
December 7, 2010 updated by: Rambam Health Care Campus
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Department of Maxillofacial Rehabillitaion School of Graduate Dentistry Rambam Health care campus
-
Sub-Investigator:
- Eli Machtei, DMD
-
Contact:
- Zvi Gutmacher, DMD
- Phone Number: +97252-5777636
- Email: dr_zviu3@netvision.net.il
-
Sub-Investigator:
- Israel Blumenfeld, DMD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patient aged 18 - 80 yrs.
- Implants treatment planned for single crown rehabilitation.
- Submerged implant placement.
- Patients willing to participate in a twelve month study.
- Up to 2 implants per patient will be allowed.
Exclusion Criteria:
- Active periodontal disease.
- Systemic condition and medication that may affect soft and hard tissue healing.
- Pregnancy or intention to become pregnant in the next twelve months.
- Parafunctional occlusal scheme and habits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
23 implants using SPK Abutments
|
implants using SPK Abutments
|
Active Comparator: Group B
implants using CPK Abutments
|
implants using CPK Abutments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 month
|
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. |
12 month post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
November 3, 2010
First Submitted That Met QC Criteria
November 3, 2010
First Posted (Estimate)
November 4, 2010
Study Record Updates
Last Update Posted (Estimate)
December 8, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- CTIL0227-10-RMB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on spk
-
Spark TherapeuticsActive, not recruitingLysosomal Storage Diseases | Glycogen Storage Disease Type II | Glycogen Storage Disease Type 2 | Pompe Disease (Late-onset) | Pompe Disease | LOPD | Acid Maltase DeficiencyUnited States, Canada, Netherlands, France, Denmark, Germany, Italy, United Kingdom
-
Spark TherapeuticsCompletedHematologic Diseases | Blood Coagulation Disorders, Inherited | Coagulation Protein Disorders | Hemorrhagic Disorders | Genetic Diseases, Inborn | Genetic Diseases, X-Linked | Gene Therapy | Blood Coagulation Disorder | Gene Transfer | Adeno-Associated Virus (AAV) | Factor VIII (FVIII) | Factor VIII (FVIII)... and other conditionsUnited States
-
PfizerActive, not recruitingHemophilia BUnited States, Canada, Australia, Turkey
-
Spark TherapeuticsActive, not recruitingHemophilia AUnited States, Canada, Australia
-
Spark TherapeuticsCompletedHemophilia AUnited States, Australia, Canada, Israel, Thailand
-
Second Affiliated Hospital of Guangzhou Medical...CompletedDiabetic Nephropathy | Perioperative/Postoperative Complications | Transplant ComplicationChina
-
Proaparts srlUnknownCryptococcosis or Aspergillosis InfectionsItaly
-
Spark Therapeutics, Inc.Recruiting
-
Phagelux Inc.Not yet recruiting