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Longitudinal Follow-up After C1 Implant Stabilization Values

A Short-term Longitudinal Follow-up After C1 Implant Stability Values.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01746160
Enrollment
10
Registered
2012-12-10
Start date
2012-12-31
Completion date
2018-02-28
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw, Edentulous, Partially

Keywords

dental implant, healing, implant stability

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).

Interventions

DRUGC1 Implant

Patients treated with dental implants.

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

open label

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in implant ISQ value.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.

Secondary

MeasureTime frameDescription
Implant Marginal Bone Loss (MBL).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.

Other

MeasureTime frameDescription
Implant survival rate.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).

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026