Longitudinal Follow-up After C1 Implant Stabilization Values
Primary Purpose
Jaw, Edentulous, Partially
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
C1 Implant
Sponsored by
About this trial
This is an interventional diagnostic trial for Jaw, Edentulous, Partially focused on measuring dental implant, healing, implant stability
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.
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C1 Implant
Arm Description
Patient having C1 implant installed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01746160
First Posted
December 3, 2012
Last Updated
August 3, 2022
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01746160
Brief Title
Longitudinal Follow-up After C1 Implant Stabilization Values
Official Title
A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
dental implant, healing, implant stability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C1 Implant
Arm Type
Experimental
Arm Description
Patient having C1 implant installed.
Intervention Type
Drug
Intervention Name(s)
C1 Implant
Other Intervention Name(s)
Treated patients, Implant cases
Intervention Description
Patients treated with dental implants.
Primary Outcome Measure Information:
Title
Change from baseline in implant ISQ value.
Description
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.
Time Frame
90 days (at end of the follow-up).
Secondary Outcome Measure Information:
Title
Implant Marginal Bone Loss (MBL).
Description
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.
Time Frame
90 days (At the end of the follow-up).
Other Pre-specified Outcome Measures:
Title
Implant survival rate.
Description
The rate of the implants found to be integrated at the end of the study (100% is anticipated).
Time Frame
90 days (At the end of the follow-up).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Organizational Affiliation
IRB coorinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
15355393
Citation
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.
Results Reference
background
PubMed Identifier
15248877
Citation
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.
Results Reference
background
PubMed Identifier
16958688
Citation
Turkyilmaz I, Sennerby L, Tumer C, Yenigul M, Avci M. Stability and marginal bone level measurements of unsplinted implants used for mandibular overdentures: a 1-year randomized prospective clinical study comparing early and conventional loading protocols. Clin Oral Implants Res. 2006 Oct;17(5):501-5. doi: 10.1111/j.1600-0501.2006.01261.x.
Results Reference
background
PubMed Identifier
16968381
Citation
Hobkirk JA, Wiskott HW; Working Group 1. Biomechanical aspects of oral implants. Consensus report of Working Group 1. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:52-4. doi: 10.1111/j.1600-0501.2006.01358.x.
Results Reference
background
PubMed Identifier
16968377
Citation
Aparicio C, Lang NP, Rangert B. Validity and clinical significance of biomechanical testing of implant/bone interface. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:2-7. doi: 10.1111/j.1600-0501.2006.01365.x.
Results Reference
background
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Longitudinal Follow-up After C1 Implant Stabilization Values
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