Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material

This study has been completed.
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01060644
First received: January 31, 2010
Last updated: November 20, 2013
Last verified: November 2013
  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 ] [ Designated as safety issue: No ]
  • CT evaluation of bone regeneration [ Time Frame: In the end of each treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01060644     History of Changes
Other Study ID Numbers: CMC-08-0015-CTIL
Study First Received: January 31, 2010
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014