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Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060644
First Posted: February 2, 2010
Last Update Posted: November 21, 2013
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.
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Carmel Medical Center
  Purpose
The present study describes and evaluates the surgical protocol for sinus mucosal lining elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting Underneath the Sinus Membrane.

Condition
Insufficient Bone Volume in Posterior Maxilla

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • CT evaluation before Dental Implant uncovering [ Time Frame: In the end of the treatment ]
  • CT evaluation of bone regeneration [ Time Frame: In the end of each treatment ]

Enrollment: 15
Study Start Date: March 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients (women, men) with a range of a age 18-65 years will be consecutively included. The patients will be referred to the Department of Oral and Maxillofacial Surgery, Carmel Medical Center, Haifa, for dental implant treatment in the posterior maxilla from every Dental Clinic in Israel
Criteria

Inclusion Criteria:

  1. Healthy patient.
  2. Patients that have a rehabilitation dentist.
  3. Healthy conditions of Maxillary Sinuses and Oral Mucosa.
  4. Healthy bone determined by Panoramic X-ray.
  5. Sub-antral bone at least 4 mm as measured on CT.
  6. Have a good oral hygiene condition.
  7. Patient that does not participate in other clinical study.
  8. Patient able to read and understand and sign the informed consent.

Exclusion Criteria:

  1. Unhealthy patients, with recorded medical history diseases as: diabetes, mellitus, heart diseases, renal failure, osteoporosis.
  2. Patients treated with anticoagulation medication (Coumadin, Plavix).
  3. Patients treated with Oral Bisphosphonate drugs (as Fosalan).
  4. Patient with a history of Chemotherapy or Radiotherapy treatment.
  5. Unhealthy conditions of Maxillary Sinuses.
  6. Patient without prosthetic rehabilitation treatment plan ) approved by the referred dentist.
  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): NCT01060644


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34326
Sponsors and Collaborators
Carmel Medical Center
Technion, Israel Institute of Technology
Investigators
Principal Investigator: Samer Srouji, DMD, Ph.D Carmel Medical Center
  More Information

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01060644     History of Changes
Other Study ID Numbers: CMC-08-0015-CTIL
First Submitted: January 31, 2010
First Posted: February 2, 2010
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Carmel Medical Center:
Maxillary Sinus
Bone Augmentation
Dental Implant
Sinus Membrane