Longitudinal Follow-up After C1 Implant Stabilization Values

August 3, 2022 updated by: Hadassah Medical Organization

A Short-term Longitudinal Follow-up After C1 Implant Stability Values.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

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

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C1 Implant
Patient having C1 implant installed.
Drug: C1 Implant
Patients treated with dental implants.
Other Names:
  • Treated patients
  • Implant cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days (at end of the follow-up).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days (At the end of the follow-up).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days (At the end of the follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Hadas Lemberg, PhD, IRB coorinator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1implantstability-HMO-CTIL

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.

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