Trial record 10 of 92 for:    Open Studies | "Jaw"

Longitudinal Follow-up After C1 Implant Stabilization Values

This study is currently recruiting participants.
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Lior Shapira, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01746160
First received: December 3, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Jaw, Edentulous, Partially
Drug: C1 Implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Short-term Longitudinal Follow-up After C1 Implant Stability Values.

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Change from baseline in implant ISQ value. [ Time Frame: 90 days (at end of the follow-up). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Implant Marginal Bone Loss (MBL). [ Time Frame: 90 days (At the end of the follow-up). ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Implant survival rate. [ Time Frame: 90 days (At the end of the follow-up). ] [ Designated as safety issue: No ]
    The rate of the implants found to be integrated at the end of the study (100% is anticipated).


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C1 Implant
Patient having C1 implant installed.
Drug: C1 Implant
Patients treated with dental implants.
Other Names:
  • Treated patients
  • Implant cases

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746160

Contacts
Contact: Lior Shapira, Prof. +972-2-6777826 shapiral@cc.huji.ac.il
Contact: Moshik Tandlich, D.M.D +972-2-6777826 tmoshik@gmail.com

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Lior Shapira, Prof.         
Sub-Investigator: Moshik Tandlich, D.M.D         
Sponsors and Collaborators
Lior Shapira
Investigators
Principal Investigator: Hadas Lemberg, PhD IRB coorinator
  More Information

Publications:
Responsible Party: Lior Shapira, Head of Dep. of Periodontology, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01746160     History of Changes
Other Study ID Numbers: C1implantstability-HMO-CTIL
Study First Received: December 3, 2012
Last Updated: September 9, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
dental implant
healing
implant stability

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on April 17, 2014