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

• Conditions: Implants; Bone Loss
• Interventions: Device: Dental Implant; Device: Platform-Matched dental implant; Device: Platform-Switch Dental Implant

• Registration Number: NCT01971268
• Lead Sponsor: Implantology Institute

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)

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 Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Study First Posted: 2013-10-29
• Last Update Posted: 2013-10-29
• Study Start: 2014-01
• Primary Completion: 2014-08
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Platform-Matched Group	Platform-Matched dental implant	T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss
Platform-Switch Group	Dental Implant	T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss
Platform-Switch Group	Platform-Switch Dental Implant	T3 dental implant, with platform-switch dental implant platform concept, measure marginal bone loss
Platform-Matched Group	Dental Implant	T3 dental implant, platform-matched dental implant platform concept, measure marginal bone loss

Primary Outcome Measures

Name	Time	Method
Position of Implant Platform to marginal bone	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.
Marginal Bone Position at 8 Weeks	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
Marginal Bone Position at 12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Osseointegration	At 12 weeks	measure the ability of the implant to integrate in bone

Trial Locations

Locations (1)

Instituto de Implantologia; 🇵🇹 Lisbon, Portugal