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

NCT ID: NCT01971268

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Implants Bone Loss

Keywords

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T3 dental implants Marginal bone loss Survival rate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Platform-Switch Group

T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss

Dental Implant

Intervention Type DEVICE

place dental implants according to manufacturer guidelines

Platform-Switch Dental Implant

Intervention Type DEVICE

Place Dental Implant with an abutment narrower than the implant platform

Platform-Matched Group

T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss

Dental Implant

Intervention Type DEVICE

place dental implants according to manufacturer guidelines

Platform-Matched dental implant

Intervention Type DEVICE

Place Dental Implant with abutment with same size as the platform

Interventions

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Dental Implant

place dental implants according to manufacturer guidelines

Intervention Type DEVICE

Platform-Switch Dental Implant

Place Dental Implant with an abutment narrower than the implant platform

Intervention Type DEVICE

Platform-Matched dental implant

Place Dental Implant with abutment with same size as the platform

Intervention Type DEVICE

Other Intervention Names

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Biomet 3i T3 dental implant Biomet 3I Dental Implant Platform-Switch Discrepant Platform implant non-matched dental implant Biomet 3I T3 Dental Implant non-discrepant platform dental implant

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Implantology Institute

OTHER

Sponsor Role lead

Responsible Party

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Andre Chen

Mcs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre Chen, Msc

Role: PRINCIPAL_INVESTIGATOR

Implantology Institute

João Caramês, Phd

Role: STUDY_DIRECTOR

Implantology Institute

Helena Francisco, Msc

Role: STUDY_CHAIR

Implantology Institute

Elena Cervino, Msc

Role: STUDY_CHAIR

Implantology Institute

Locations

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Instituto de Implantologia

Lisbon, Lisbon District, Portugal

Site Status

Countries

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Portugal

Central Contacts

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André Chen, Msc

Role: CONTACT

Phone: 00351919774343

Email: [email protected]

Elena Cervino, Msc

Role: CONTACT

Phone: 00351919074338

Email: [email protected]

Facility Contacts

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Joana Velez

Role: primary

Other Identifiers

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II-02

Identifier Type: -

Identifier Source: org_study_id