Compare the Success Rate of T3 Dental Implant (Biomet 3I) With or Without Platform-switch Concept

October 23, 2013 updated by: Andre Chen, Implantology Institute

Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols

In patients that received a T3 (Biomet 3I) dental implant, does the use of platform-switch concept compared to the use of platform-matched concept, refrain marginal bone loss during osseointegration phase (t=12 weeks =T1) and from then to final rehabilitation (t= placement of the final restoration = at 18 weeks=T2)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients from a private practice who received dental implants (T3 dental implant Biomet 3I) from November 2012 to October 2013 were eligible to enter the study.

Two groups were formed: one group received a T3 dental implant with platform switch concept and the other received an implant with platform matched type of connection.

We evaluate osseointegration at T1 (12 weeks) and marginal bone position in relation to the implant platform at baseline (implant installation) T0 and again at T1 and T2.

From data recorder in T0,T1 and T2, we evaluate changes in marginal bone position.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1500-662
        • Instituto de Implantologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population from a private office who seek care to replace missing teeth, must have economical status to do implant supported rehabilitations

Description

Inclusion Criteria:

  • Single unit implant rehabilitation
  • Maxilla and mandible
  • Biomet 3I T3 dental implant placed
  • Final Rehabilitation placed

Exclusion Criteria:

  • Immediate implants
  • Radiographic impossibility of measure
  • Absence of baseline T0 radiograph
  • Smoking habits (more 10 cigarets a day)
  • Diabetes
  • Patients who receive Radio or/and Chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Platform-Switch Group
T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss
Device: Dental Implant
place dental implants according to manufacturer guidelines
Other Names:
  • Biomet 3i T3 dental implant
Device: Platform-Switch Dental Implant
Place Dental Implant with an abutment narrower than the implant platform
Other Names:
  • Biomet 3I Dental Implant Platform-Switch
  • Discrepant Platform implant
  • non-matched dental implant
Platform-Matched Group
T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss
Device: Dental Implant
place dental implants according to manufacturer guidelines
Other Names:
  • Biomet 3i T3 dental implant
Device: Platform-Matched dental implant
Place Dental Implant with abutment with same size as the platform
Other Names:
  • Biomet 3I T3 Dental Implant
  • non-discrepant platform dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Position of Implant Platform to marginal bone
Time Frame: At Baseline (T0)
Compare marginal bone position at baseline T0 (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
At Baseline (T0)
Marginal Bone Position at 8 Weeks
Time Frame: At 12 weeks (T1) after Baseline
Compare marginal bone position at T1, 12 weeks after baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform
At 12 weeks (T1) after Baseline
Marginal Bone Position at 12 Weeks
Time Frame: At 18 Weeks (T2) after baseline (T0)
Compare marginal bone position at T2, 18 weeks from baseline (T0) (measured radiographically (digital) from the most coronal position of marginal bone to the most coronal position of the platform, measured in the most mesial and distal part (two measures) of the implant platform.
At 18 Weeks (T2) after baseline (T0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osseointegration
Time Frame: At 12 weeks
measure the ability of the implant to integrate in bone
At 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Implantology Institute

Investigators

  • Principal Investigator: Andre Chen, Msc, Implantology Institute
  • Study Chair: Helena Francisco, Msc, Implantology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • II-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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