Clinical trial NCT01746160: Longitudinal Follow-up After C1 Implant Stabilization Values
Official title: A Short-term Longitudinal Follow-up After C1 Implant Stability Values.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: dental implant
healing
implant stability
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Change from baseline in implant ISQ value.
timeFrame: 90 days (at end of the follow-up).
Secondary outcomes:
measure: Implant Marginal Bone Loss (MBL).
timeFrame: 90 days (At the end of the follow-up).
Other outcomes:
measure: Implant survival rate.
timeFrame: 90 days (At the end of the follow-up).
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: IRB coorinator
name: Hadas Lemberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.