Longitudinal Follow-up After C1 Implant Stabilization Values

Jaw, Edentulous, Partially Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746160
• Other study ID #: C1implantstability-HMO-CTIL
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Drug:
• C1 Implant
Patients treated with dental implants.

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. Review. — View Citation

Glauser R, Sennerby L, Meredith N, Rée A, Lundgren A, Gottlow J, Hämmerle 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implant survival rate.	The rate of the implants found to be integrated at the end of the study (100% is anticipated).	90 days (At the end of the follow-up).
Primary	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.	90 days (at end of the follow-up).
Secondary	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.	90 days (At the end of the follow-up).