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Completed

NCT Number: NCT01746160

Longitudinal Follow-up After C1 Implant Stabilization 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

C1 Implant

Drug

Patients treated with dental implants.

Other names: Treated patients, Implant cases

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2012
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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