Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

Inflammation Clinical Trial

Official title:

Healing Response if Peri-implant Tissues to Different Abutment Materials - Double-blinded Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961635
• Other study ID #: II-01
• Status: Completed
• Phase: N/A
• First received: October 6, 2013
• Last updated: April 29, 2017
• Start date: January 2016
• Est. completion date: March 23, 2017

Study information

• Verified date: April 2017
• Source: Instituto de Implantologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Inflammation

Intervention

Device:
• dental implants
place implant according fabricant guidelines, 2mm sub-crestally
• Zirconia abutments
place zirconia abutment on the day of implant placement
• Titanium Abutments
place titanium abutment on the day of implant placement
• cad-cam acrylic abutments
place cad-cam acrylic abutment on the day of implant placement

Procedure:
• Subcrestal
place implant 2mm below crestal bone

Device:
• platform-switch
abutment platform is narrow than implant diameter

Procedure:
• one-time one-abutment
place the final abutment on the day of surgery and not remove it
• Torque 20 n/cm2
the amount of torque applied to the abutment

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina Dentária de Lisboa	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	Gingival Inflammatory Changes from baseline to 12 weeks	measure the amount of cytokines and interleukines (interleukin-8 (IL-8), macrophage inflammatory protein-1 (MIP-1 beta), interleukin-1 (IL-1 beta), interleukin-6 (IL-6), matrix metalloproteinase-8 (MMP-8) and matrix metalloproteinase-9 (MMP-9), metallopeptidase inhibitor 1 (TIMP-1), vascular endothelial growth factor (VEGF)), around different implant abutment materials, zirconia,titanium, acrylic, and cad-cam acrylic	Measure - T0 Implant installation T1- 1week post-surgery T2-two weeks T3-3weeks T4-4weeks T5-6weeks T6-8weeks T7-12 weeks
Secondary	Marginal Bone Loss	Parallel periapical standardized radiographs to measure bone position in relation to implant platform, in zirconia,titanium, acrylic, and cad-cam acrylic	measured at 12 weeks post-implant installation
Secondary	Gingival height	measure with periodontal probe distance from implant platform to the most coronal point of gingival margin mesial, distal, buccal and lingual,in zirconia,titanium, acrylic, and cad-cam acrylic	12 weeks post-implant installation
Secondary	Osseointegration	compare survival rate of dental implants rehabilitated with zirconia,titanium, acrylic, and cad-cam acrylic abutments	12 weeks post-implant installation
Secondary	Height from gingiva to abutment	height from gingival margin to most coronal point of the abutment in zirconia, titanium, acrylic and acrylic cad-cam abutments	12 weeks post implant installation