Longitudinal Follow-up After C1 Implant Stabilization Values | NCT01746160

Studies
Longitudinal Follow-up After C1 Implant Stabilization Values

NCT01746160

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Aug 5, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Jaw, Edentulous, Partially

Interventions

C1 Implant

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Dec 3, 2012

First Submission Date that Met QC Criteria

Dec 6, 2012

First Posted Date

Dec 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2022

Last Update Posted Date

Aug 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C1 Implant	Experimental	Patient having C1 implant installed.	Drug: C1 Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C1 Implant	Drug	Patients treated with dental implants.	C1 Implant	Treated patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in implant ISQ value.	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 Outcomes

Measure	Description	Time Frame
Implant Marginal Bone Loss (MBL).	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 Outcomes

Measure	Description	Time Frame
Implant survival rate.	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).

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hadas Lemberg, PhD	IRB coorinator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15355393	Background	Nedir R, Bischof M, Szmukler-Moncler S, Bernard JP, Samson J. Predicting osseointegration by means of implant primary stability. Clin Oral Implants Res. 2004 Oct;15(5):520-8. doi: 10.1111/j.1600-0501.2004.01059.x.
15248877	Background	Glauser R, Sennerby L, Meredith N, Ree A, Lundgren A, Gottlow J, Hammerle CH. Resonance frequency analysis of implants subjected to immediate or early functional occlusal loading. Successful vs. failing implants. Clin Oral Implants Res. 2004 Aug;15(4):428-34. doi: 10.1111/j.1600-0501.2004.01036.x.

ID	Term
D007575	Jaw, Edentulous
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D009057	Stomatognathic Diseases