Hadassah Medical Organization
Jerusalem, Israel
NCT Number: NCT01746160
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Jerusalem, Israel
10 Patients requiring standard implant installation in their maxilla will be recruited to the study.
Inclusion criteria
Exclusion criteria
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients treated with dental implants.
Other names: Treated patients, Implant cases
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.
Time frame: 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.
Time frame: 90 days (At the end of the follow-up).
The rate of the implants found to be integrated at the end of the study (100% is anticipated).
Hadassah Medical Organization
Other
A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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