Overview

This trial is active, not recruiting.

Conditions bone loss, inflammation
Treatments dental implants, zirconia abutments, titanium abutments, cad-cam acrylic abutments, subcrestal, platform-switch, one-time one-abutment, torque 20 n/cm2
Sponsor Instituto de Implantologia
Start date January 2016
End date August 2018
Trial size 60 participants
Trial identifier NCT01961635, II-01

Summary

In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Place zirconia one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
dental implants T3 - Biomet 3I Implants
place implant according fabricant guidelines, 2mm sub-crestally
zirconia abutments Zirconia cad-cam abutment
place zirconia abutment on the day of implant placement
subcrestal
place implant 2mm below crestal bone
platform-switch
abutment platform is narrow than implant diameter
one-time one-abutment one time abutment
place the final abutment on the day of surgery and not remove it
torque 20 n/cm2 manual torque
the amount of torque applied to the abutment
(Experimental)
Place titanium one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
dental implants T3 - Biomet 3I Implants
place implant according fabricant guidelines, 2mm sub-crestally
titanium abutments Titanium Encode - biomet 3I Implants
place titanium abutment on the day of implant placement
subcrestal
place implant 2mm below crestal bone
platform-switch
abutment platform is narrow than implant diameter
one-time one-abutment one time abutment
place the final abutment on the day of surgery and not remove it
torque 20 n/cm2 manual torque
the amount of torque applied to the abutment
(Experimental)
Place cad-cam acrylic one-time one-abutment in subcrestal platform-switch dental implants on the day of implant installation, torque 20 n/cm2
dental implants T3 - Biomet 3I Implants
place implant according fabricant guidelines, 2mm sub-crestally
cad-cam acrylic abutments Cad-cam acrylic abutment
place cad-cam acrylic abutment on the day of implant placement
subcrestal
place implant 2mm below crestal bone
platform-switch
abutment platform is narrow than implant diameter
one-time one-abutment one time abutment
place the final abutment on the day of surgery and not remove it
torque 20 n/cm2 manual torque
the amount of torque applied to the abutment

Primary Outcomes

Measure
Gingival Inflammatory Changes from baseline to 12 weeks
time frame: Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks

Secondary Outcomes

Measure
Marginal Bone Loss
time frame: measured at 12 weeks post-implant installation
Gingival height
time frame: 12 weeks post-implant installation
Osseointegration
time frame: 12 weeks post-implant installation
Height from gingiva to abutment
time frame: 12 weeks post implant installation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Single unit implant rehabilitation - Maxilla and mandible - Must accept treatment plan - Must sign informed consent - dental extraction performed at least 3 month prior - Must have at least 6 mm of residual bone - Absence of oral lesions - keratinized tissue must be present Exclusion Criteria: - If smoking and/or other drug addiction is present - If local anesthetic allergy is present - Patient subjected to chemical or radiotherapy - if Hepatic disease is present - If immunodepression is present - If Pregnancy is present - If Diabetes is present - If Heart disease is present

Additional Information

Official title Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial
Principal investigator João Caramês, Phd
Description Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Instituto de Implantologia.