Longitudinal Follow-up After C1 Implant Stabilization Values
NCT ID: NCT01746160
Last Updated: 2022-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2012-12-31
2018-02-28
Brief Summary
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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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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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C1 Implant
Patient having C1 implant installed.
C1 Implant
Patients treated with dental implants.
Interventions
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C1 Implant
Patients treated with dental implants.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Principal Investigators
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Hadas Lemberg, PhD
Role: PRINCIPAL_INVESTIGATOR
IRB coorinator
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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C1implantstability-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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