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

Bone Loss Clinical Trial

Official title:

Marginal Bone Behavior of Dental Implants to Different Rehabilitation Protocols

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01971268
• Other study ID #: II-02
• Status: Not yet recruiting
• Phase: N/A
• First received: October 17, 2013
• Last updated: October 23, 2013
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2013
• Source: Instituto de Implantologia
• Contact: André Chen, Msc
• Phone: 00351919774343
• Email: tsouchen[@]gmail.com
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Loss
• Implants

Intervention

Device:
• Dental Implant
place dental implants according to manufacturer guidelines
• Platform-Switch Dental Implant
Place Dental Implant with an abutment narrower than the implant platform
• Platform-Matched dental implant
Place Dental Implant with abutment with same size as the platform

Locations

Country	Name	City	State
Portugal	Instituto de Implantologia	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Implantologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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	Yes
Primary	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)	Yes
Secondary	Osseointegration	measure the ability of the implant to integrate in bone	At 12 weeks	Yes