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Longitudinal Follow-up After C1 Implant Stabilization Values

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ClinicalTrials.gov Identifier: NCT01746160
Recruitment Status : Unknown
Verified September 2013 by Lior Shapira, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Lior Shapira, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
Change from baseline in implant ISQ value. [ Time Frame: 90 days (at end of the follow-up). ]
The change in implants' stability values that were measured by an 'Osstell' appliance at the end of the study as compared to their baseline value.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01746160 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
Implant Marginal Bone Loss (MBL). [ Time Frame: 90 days (At the end of the follow-up). ]
The amount of the marginal bone loss (MBL) as measured by comparing two intra-oral radiogram taken right after the operation and at the end of the follow-up period.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 6, 2012)
Implant survival rate. [ Time Frame: 90 days (At the end of the follow-up). ]
The rate of the implants found to be integrated at the end of the study (100% is anticipated).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Longitudinal Follow-up After C1 Implant Stabilization Values
Official Title  ICMJE A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
Brief Summary

The aim of the study is to describe the changes found in C1 dental implants through their early healing period.

Patients requiring a standard installation of one or two implants in the maxilla, without any need for bone augmentation, will be frequently followed for 90 days. In every meeting the implants' ISQ values (values denoting the implant stability as being measured by a dedicated, commercially available, appliance called 'Osstell').

The implants' measured ISQ values will be used to describe the changes that may be found in the implants' stability through their healing period.

At the end of the study the patients will be referred to their treating doctor for the completion of implants' restoration (i.e. crown).

Detailed Description

10 Patients requiring standard implant installation in their maxilla will be recruited to the study.

Inclusion criteria:

  • Men and women over the age of 18.
  • The patient will be willing, and will be available to attend all the follow-up meetings.
  • The patient will accept and sign an informed consent form before the beginning of the study.

Exclusion criteria:

  • Pregnant women or women who are breast feeding.
  • Patient suffering of untreated periodontal disease.
  • Patient who smoke more than 10 cigarettes per day.
  • Alcohol abuse.
  • Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.
  • Patient who need some bone augmentation prior.
  • Immediate implant placement or restorations.

Course of study:

Every patient found eligible to the study will need to go through a CT scan of the implantation site (as required).

Before the operation 2 gr of AMOXICILLIN (or 600mg of CLYNDAMYCIN - in case of allergy) will be administered. The implants will be installed in a standard approach under local anesthesia, as customary being done. The implants' installation torque will be recorded.

At the end of the operation the patients will be instructed to rinse their mouth with Chlorhexidine solution for one week.

Eventually the implants will be restored and loaded after the common 3 months healing period.

Follow-up appointments:

The patients will be monitored through a period of 3 months. The patients will be instructed to return to a follow-up examination 2, 4, 7, 14, 21, 28, 45, 60 and 90 days after the operation. On each meeting the implants' ISQ values will be measured using an 'Osstell' appliance.

An x-ray intra-oral radiogram will be taken right after the end of the operation and at the end of the follow-up (i.e day 90).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Jaw, Edentulous, Partially
Intervention  ICMJE Drug: C1 Implant
Patients treated with dental implants.
Other Names:
  • Treated patients
  • Implant cases
Study Arms  ICMJE Experimental: C1 Implant
Patient having C1 implant installed.
Intervention: Drug: C1 Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 6, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women over the age of 18.
  • The patient will be willing, and will be available to attend all the follow-up meetings.
  • The patient will accept and sign an informed consent form before the beginning of the study.

Exclusion criteria:

  • Pregnant women or women who are breast feeding.
  • Patient suffering of untreated periodontal disease.
  • Patient who smoke more than 10 cigarettes per day.
  • Alcohol abuse.
  • Patient suffering of either uncontrolled Diabetes, Osteoporosis, rheumatic arthritis, neoplastic or pre-cancerous condition, or any other condition limiting standard implant installation procedure.
  • Patient who need some bone augmentation prior.
  • Immediate implant placement or restorations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01746160
Other Study ID Numbers  ICMJE C1implantstability-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lior Shapira, Hadassah Medical Organization
Study Sponsor  ICMJE Lior Shapira
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hadas Lemberg, PhD IRB coorinator
PRS Account Hadassah Medical Organization
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP