NCT01746160

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 5, 2022

Status Verified

September 1, 2016

Enrollment Period

5.2 years

First QC Date

December 3, 2012

Last Update Submit

August 3, 2022

Conditions

Jaw, Edentulous, Partially

Keywords

dental implanthealingimplant stability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Implant Marginal Bone Loss (MBL).

    90 days (At the end of the follow-up).

Other Outcomes (1)

  • Implant survival rate.

    90 days (At the end of the follow-up).

Study Arms (1)

C1 Implant

EXPERIMENTAL

Patient having C1 implant installed.

Drug: C1 Implant

Interventions

C1 ImplantDRUG

Patients treated with dental implants.

Also known as: Treated patients, Implant cases
C1 Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (5)

  • 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.

    PMID: 15355393BACKGROUND

  • 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.

    PMID: 15248877BACKGROUND

  • 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.

    PMID: 16958688BACKGROUND

  • 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.

    PMID: 16968381BACKGROUND

  • 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.

    PMID: 16968377BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Hadas Lemberg, PhD

    IRB coorinator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 10, 2012

Study Start

December 1, 2012

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 5, 2022

Record last verified: 2016-09

Locations

IL(1)