Longitudinal Follow-up After C1 Implant Stabilization Values

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Drug: C1 Implant

• Registration Number: NCT01746160
• Lead Sponsor: Hadassah Medical Organization

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Status Verified: 2016-09
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C1 Implant	C1 Implant	Patient having C1 implant installed.

Primary Outcome Measures

Name	Time	Method
Change from baseline in implant ISQ value.	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 Outcome Measures

Name	Time	Method
Implant Marginal Bone Loss (MBL).	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.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel