Jaw, Edentulous, PartiallyNCT01746160
Longitudinal Follow-up After C1 Implant Stabilization Values
A study testing C1 Implant in people with Jaw, Edentulous, Partially, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- C1 Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Short-term Longitudinal Follow-up After C1 Implant Stability 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').
Read more
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).
Read the 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).
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- C1 Implant
- Keywords
- dental implant, healing, implant stability
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1 ImplantDrug
Also called Treated patients, Implant cases
Patients treated with dental implants.
| Study group | Role | What they receive |
|---|---|---|
| C1 Implant | Experimental | Patient having C1 implant installed. Receives: Drug: C1 Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days (at end of the follow-up).
Secondary outcomes (1)
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.
Measured: 90 days (At the end of the follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadas Lemberg, PhD, Principal investigator, IRB coorinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746160
- Sponsor's protocol ID
- C1implantstability-HMO-CTIL
- Status last verified
- Sep 2016
- First submitted
- 3 Dec 2012
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15355393Glauser 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.
PubMed 15248877Turkyilmaz 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.
PubMed 16958688Hobkirk 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.
PubMed 16968381Aparicio 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.
PubMed 16968377
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
- ClinicalTrials.gov ID
- NCT01746160
- Acronym / sponsor ID
- C1implantstability-HMO-CTIL
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- dental implant, healing, implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C1 Implant | Experimental | Drug: C1 ImplantPatient having C1 implant installed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1 ImplantAlso: Treated patients, Implant casesPatients treated with dental implants. | Drug | C1 Implant |
Primary outcome
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.
1 secondary outcome
Implant Marginal Bone Loss (MBL).
Time frame: 90 days (At the end of the follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 15355393Nedir 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.
- Background: PubMed 15248877Glauser 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.
- Background: PubMed 16958688Turkyilmaz 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.
- Background: PubMed 16968381Hobkirk 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.
- Background: PubMed 16968377Aparicio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadas Lemberg, PhD principal investigator
IRB coorinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C1 Implant in people with Jaw, Edentulous, Partially, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in implant ISQ value. (time frame: 90 days (at end of the follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746160, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.