NCT01971268

Brief Summary

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)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 17, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

October 17, 2013

Last Update Submit

October 23, 2013

Conditions

ImplantsBone Loss

Keywords

T3 dental implantsMarginal bone lossSurvival rate

Outcome Measures

Primary Outcomes (3)

  • Position of Implant Platform to marginal bone

    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

    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

    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 Outcomes (1)

  • Osseointegration

    At 12 weeks

Study Arms (2)

Platform-Switch Group

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

Device: Dental ImplantDevice: Platform-Switch Dental Implant

Platform-Matched Group

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

Device: Dental ImplantDevice: Platform-Matched dental implant

Interventions

Dental ImplantDEVICE

place dental implants according to manufacturer guidelines

Also known as: Biomet 3i T3 dental implant
Platform-Matched GroupPlatform-Switch Group
Platform-Switch Dental ImplantDEVICE

Place Dental Implant with an abutment narrower than the implant platform

Also known as: Biomet 3I Dental Implant Platform-Switch, Discrepant Platform implant, non-matched dental implant
Platform-Switch Group
Platform-Matched dental implantDEVICE

Place Dental Implant with abutment with same size as the platform

Also known as: Biomet 3I T3 Dental Implant, non-discrepant platform dental implant
Platform-Matched Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Implantologia

Lisbon, Lisbon District, 1500-662, Portugal

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Andre Chen, Msc

    Implantology Institute

    PRINCIPAL INVESTIGATOR

  • João Caramês, Phd

    Implantology Institute

    STUDY DIRECTOR

  • Helena Francisco, Msc

    Implantology Institute

    STUDY CHAIR

  • Elena Cervino, Msc

    Implantology Institute

    STUDY CHAIR

Central Study Contacts

André Chen, Msc

CONTACT

00351919774343tsouchen@gmail.com

Elena Cervino, Msc

CONTACT

00351919074338elecer@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mcs

Study Record Dates

First Submitted

October 17, 2013

First Posted

October 29, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

PT(1)